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Initial U.S. pilot study: palatal implants for the treatment of snoring.

OBJECTIVE: To assess efficacy of polyethylene terephthalate (PET) implants in the soft palate for the treatment of socially significant snoring. DESIGN: A prospective, interventional case series. SETTING: Hospital-based multi-specialty clinic. PATIENTS: Twenty-five consecutive patients with socially significant snoring without history of obstructive sleep apnea. INTERVENTION: Three PET implants were inserted into the soft palate of each patient (Pillar procedure, Restore Medical, Inc., St. Paul, Minnesota). MAIN OUTCOME MEASURE: Change in snoring severity measured by the bed partner using a 10-centimeter visual analog scale (VAS) where 0 = "no snoring noise" and 10 = "extreme snoring noise causing (the bed partner) to leave the bedroom." RESULTS: Ninety-day follow-up data was collected for 21 patients. Four patients had incomplete follow-up. Snoring VAS rated by the bed partner had a baseline mean value of 8.5 +/- 1.4, which decreased to 5.0 +/- 2.1 at 30 days and to 4.4 +/- 2.5 at 90 days (P < 0.001). All patients tolerated the procedure well and no procedure-related complications were observed. Two implants partially extruded in 1 patient within the 90-day follow-up period, for an implant partial extrusion rate of 2.7% (2/75 implants) and patient partial extrusion rate of 4% (1/25 patients). At 90 days, 75% of patients and 90% of their bed partners recommended the procedure. CONCLUSIONS: In this case series, PET implants into the soft palate significantly reduced snoring with few extrusions and no complications. Controlled studies are needed to confirm effectiveness and to refine patient selection criteria. EBM RATING: C-4.

Adult↗

Rhinitis and snoring as risk factors for hypertension in post-menopausal women.

OBJECTIVE: Several studies have suggested an association between snoring and hypertension. An association between rhinitis and hypertension has been recently indicated in men but not in women. Since menopausal status is an important determinant of blood pressure, we evaluated the relationship between rhinitis, snoring and blood pressure taking into account the modifying effect of menopausal status. DESIGN: Cross-sectional survey. SETTINGS: Four areas of Italy: the Po river Delta, Pisa (Tuscany), Viterbo (Lazio) and Rome. MAIN OUTCOME MEASURES: Data were collected by a questionnaire and a medical visit. PARTICIPANTS: One thousand five hundred and fifty-four female non-smokers. RESULTS: Systolic blood pressure (SBP) was significantly related to both occasional and habitual snoring in the overall sample. No associations were found between SBP, snoring, and rhinitis in pre-menopausal women. Both occasional and habitual snoring, but not rhinitis, were significant risk factors for increased SBP in women who stopped menstruating fewer than 11 years previously (beta=10.27 mmHg, 95% confidence interval (CI)=3.5, 17.01 and beta=9.91 mmHg, 95% CI=2.3, 17.5, respectively). However, women who had been menopausal for more than 11 years were found to have an increased SBP if they were occasional snorers (beta=8.94 mmHg 95% CI=1.2, 16.6) or habitual snorers (beta=8.01 mmHg, 95% CI=0.10, 15.9). The increase in SBP was even greater in these women when habitual snoring was associated with rhinitis (beta=11.96 mmHg, 95% CI=1.01, 22.9). CONCLUSION: We suggest that the association of snoring with rhinitis may facilitate the development of apnea during sleep, which in post-menopausal women may increase the risk of developing hypertension.

Adult↗

Blood pressure, snoring, obesity, and nocturnal hypoxaemia.

The association between snoring and blood pressure is still a matter for debate, partly because of uncertainty about the definition of snoring and partly because confounding factors may affect systemic blood pressure such as obesity, sleep apnoea, and nocturnal hypoxaemia. To isolate the contribution of each of these factors, 1415 patients (389 females, 1026 males) referred to a sleep disorders centre were studied. A full history was obtained with particular attention to cardiovascular disease and medications. The patients had nocturnal polysomnography including objective measurement of snoring, and blood pressure was measured in the morning. 18% of non-snores had hypertension as did 20% of heavy snores (not significantly different). Multivariate linear regression analysis showed that snoring was not a significant determinant of blood pressure. Only age, male sex, apnoea/hypopnoea index, and body mass index contributed significantly to the variability of blood pressure. We conclude that snoring in the absence of sleep apnoea is not associated with raised blood pressure.

Adolescent↗

Midline radiofrequency tissue reduction of the palate for bothersome snoring and sleep-disordered breathing: A clinical trial.

This study is a prospective, nonrandomized clinical trial initiated to assess the safety and efficacy of radiofrequency tissue reduction of the palate for the treatment of bothersome snoring and sleep-disordered breathing. Twelve healthy volunteers with socially disruptive snoring underwent a baseline polysomnogram along with a battery of visual analog scales (VASs) to measure daytime sleepiness, snoring level, pain, and disturbances of speech and swallowing. After radiofrequency tissue reduction of the palate, they were re-evaluated with a mean follow-up after the final procedure of 15.7 +/- 5.1 (mean +/- SD) weeks. As rated by the bed partner, a significant reduction in the level of snoring occurred in all 12 patients, with a mean pretreatment snoring level of 8.3 +/- 2.1 to a mean posttreatment snoring level of 2.1 +/- 1.4. (Student t test, P < 0.0001) These patients required an average of 2.3 treatment sessions each. Nine of 12 had a reduction in snoring from a bothersome level (VAS range 5-10) to a nonbothersome level (VAS range 0-3). Daytime sleepiness as measured by the Epworth Sleepiness Scale (0-24) decreased from 10.8 +/- 4.4 to 8.3 +/- 4.1 (P = 0.011). Posttreatment pain was considered absent or minimal in 11 of 12 patients and was managed with acetaminophen. No significant adverse events or complications were reported.

Adolescent↗

Snoring as a cause of nocturia in men with lower urinary tract symptoms.

OBJECTIVES: Snoring increases with increasing age and body mass, and repeated periods of hypoxia cause nocturnal polyuria. Accordingly, we examined the occurrence of snoring problems in patients scheduled for transurethral prostatic resection. METHODS: Of 171 men scheduled for TUR-P, 41 were excluded due to cardiac disease, diabetes, or prostatic malignancy. Of the remaining 130 patients, 12% were troubled by snoring that disturbed their sleep. The severity of their snoring was evaluated by questionnaires, micturition charts, and determination of nocturnal capillary oxygen saturation (SaO(2)) and pulse rate. Plasma levels of cortisol, arginine vasopressin (AVP), and atrial natriuretic peptide (ANP) were measured in the morning and at 2 p.m. Fifteen non-snoring patients also scheduled for TUR-P served as controls. RESULTS: Compared to controls, the snoring patients had a significantly higher body mass index (BMI), voided more frequently, and produced more urine at night. They also had a significantly larger number of hypoxic episodes at night, which, along with low SaO(2) levels, correlated with the nocturnal diuresis. Snorers did not differ significantly from controls in regard to excretion of cortisol and AVP, but they did have higher plasma levels of ANP. CONCLUSIONS: We recommend that elderly obese men with urgency at night be questioned about snoring, and that micturition frequency and volume charts be completed before deciding to operate.

Age Factors↗

Effects of Breathe Right on snoring: a polysomnographic study.

The nasal vestibule is a major site of resistance to airflow in healthy subjects. A high nasal resistance may increase snoring. Activation of the alae nasi and alar retraction reduce resistance to airflow and improve ventilation. The Breathe Right (BR) device has been proposed to reduce or eliminate snoring by improving nasal breathing. We assessed the efficacy of BR on sleep quality and snoring during 2 full-night polysomnographies, the first without and the second with BR. Ten non-apnoeic snorers were studied. Snoring was present during 22-98% of total sleep time during the control night. Ear-nose-throat examination disclosed a nasal valve anomaly in five subjects, objectivated by anterior and posterior rhinomanometry. Quality of sleep and snoring were not influenced by BR, even when different sleep stages were analysed separately. No difference in snoring index was found between snorers with or without nasal valve anomaly. We conclude that BR is ineffective in relieving snoring in non-apnoeic snorers.

Adult↗

A new method for evaluating and reporting the severity of snoring.

We propose a new questionnaire-based method for evaluating and reporting the severity of snoring, the snoring scale score (SSS), which provides an assessment of the loudness, frequency and periodicity of snoring sound. Ninety-nine patients with snoring problems were assessed and the results of 19 patients who underwent surgery to reduce snoring were reported using the SSS and the linear analogue score (LAS) at six weeks and six months after surgery. All patients reported reduction of snoring on both the SSS and LAS after surgery although minor discrepancies of reporting were found in six patients when comparisons were made between reporting of outcome using the SSS and LAS. Our study suggested that the SSS offers a uniform, comprehensive and simple to understand method for the evaluation, grading and reporting of snoring which is not currently available.

Adult↗

Uvulopalatopharyngoplasty versus laser assisted uvulopalatoplasty for the treatment of snoring: an objective randomised clinical trial.

This study was designed to evaluate objectively the clinical effectiveness of surgery for snoring and to compare the results of conventional uvulopalatopharyngoplasty (UPPP) and laser assisted uvulopalatoplasty (LAUP) in the treatment of snoring. Patients who had been referred for investigation and treatment of their snoring were randomly allocated to receive either UPPP or LAUP. Forty-seven patients with confirmed palatal flutter had surgery and all of them had a preoperative and postoperative objective assessment of their snoring loudness and duration in the home. The recording device (Snore Box) is simple for the patient to operate, portable with a built in microphone, and able to produce objective results, which can be automatically analysed. Of the 38 patients, who had technically valid recordings, 22 underwent LAUP and 16 UPPP. Overall the mean postoperative Snore Index (SI) was less than the preoperative SI (P < 0.0001), the average difference being 78.2 snores/h. There was no significant difference between the LAUP and UPPP regarding the fall in the SI. This study is the first objective comparative study to demonstrate the effectiveness of snoring surgery.

Adult↗

Changes in snoring during natural sleep identified by acoustic crest factor analysis at different times of night.

Sleep nasendoscopy can be used to identify the site of snoring but questions remain about how well a short assessment during drug-induced sleep reflects the natural condition. To investigate the uniformity of snoring during natural sleep we studied five patients (three men, two women) referred by their GPs for treatment of their snoring. A digital audio tape recorder captured the free-field snore sound at different times of night in hospital. Acoustic Crest Factor values were calculated on the 15 recordings made, having previously demonstrated that high crest factor values distinguish palatal from non-palatal snoring at sleep nasendoscopy. Some recordings showed reproducibility, but others showed substantial changes between recordings an hour apart. We infer that the snoring mechanism may change in some individuals during the night, with or without a change of snore site. We conclude a single recording, as in sleep nasendoscopy, may not be representative.

Acoustics↗

Palatal surgery for snoring: objective long-term evaluation.

Snoring surgery has mainly been assessed in the literature using subjective outcome measures with some evidence to indicate that the benefits of surgery are short lived. There is remarkably little published on the objective outcome of snoring surgery. We reported previously short-term (2-11 months) objective results on 38 patients who had palatal surgery. All the patients had preoperative and postoperative objective assessment of their snoring loudness and duration in the home. The current study presents the long-term objective results of 24 patients from the same cohort. All patients who were included in our study had palatal snoring confirmed on sleep nasendoscopy. and none of them had significant obstructive sleep apnoea. The median follow-up period was 45 months (range 29-56 months). Overall, the mean snore index (SI) at long-term follow-up was significantly less than the preoperative SI (P < 0.0001). There was no significant difference between the short-term and the long-term results regarding the fall in the SI. This study is the first to use postoperative objective assessment in the home and to demonstrate that snoring reduction is maintained for several years after snoring surgery.

Endoscopy↗

Submucosal radiosurgical uvulopalatoplasty for the treatment of snoring: Is the monitoring of tissue impedance and temperature necessary?

OBJECTIVE: To determine the safety and efficacy of submucosal radiofrequency uvulopalatoplasty. This procedure uses fixed, predetermined parameters of application without the concomitant monitoring of tissue impedance and temperature in the submucosal radiofrequency induced ablation and volumetric reduction of the soft palate as a treatment of chronic socially disruptive snoring. DESIGN: This nonrandomized prospective study used preoperative and postoperative questionnaires and visual analogue scales to evaluate snoring and postoperative pain. SETTING: Treatments were performed on an outpatient basis in a community-based clinic. PATIENTS: Nineteen patients sought treatment for chronic socially disruptive snoring, without complaints of excessive daytime somnolence, who met the predetermined criteria of a respiratory distress index of less than 20. INTERVENTION: Radiofrequency energy (3.8 MHZ) was applied to the submucosal tissues of the soft palate through a specially designed needle electrode with a predetermined wattage and treatment time. The number of treatments ranged from 1 to 6 (mean, 3.1). Resolution of snoring or diminution of snoring, to the point where it was no longer bothersome to the patients' bedmate, was considered the successful endpoint of the treatments. RESULTS: Sixteen patients were successfully treated and satisfied with the results. Three patients had only mild or moderate improvement in snoring despite multiple treatments. Postoperative pain was rated as mild (< or = 3 on the visual analogue scale) in 86% of treatments. In 8 (14%) of 58 treatments, mucosal injury was inadvertently sustained, but all healed without complications. CONCLUSION: Submucosal radiofrequency uvulopalatoplasty, using the described technique, appears to be a safe, effective, and well-tolerated treatment for chronic socially disruptive snoring. These initial results indicate that the concomitant monitoring of tissue impedance and tissue temperature during radiofrequency ablation and volumetric reduction of the soft palate is not necessary and adds significantly to the cost of the procedure.

Adult↗

Injection snoreplasty: how to treat snoring without all the pain and expense.

OBJECTIVE: We introduce Injection Snoreplasty: an innovative, safe, and effective palatal snoring procedure with minimal cost and discomfort to the patient. A well-described sclerotherapy agent, Sotradecol, is injected into the soft palate to reduce/eliminate palatal flutter snoring. STUDY DESIGN AND SETTING: Twenty-seven patients with a diagnosis of palatal flutter snoring (respiratory disturbance index less than 10) by sleep study were enrolled in the protocol. Office treatment sessions were performed 6 to 8 weeks apart. Success was judged by subjective improvement in snoring and objective evidence of palatal stiffening/scarring. RESULTS: Twenty-five (92%) of 27 patients reported significant decrease in snoring. There were no significant postinjection complications. Visual analog pain scale confirmed minimal discomfort. Most patients received more than 1 treatment (average, 1.8) in order to receive optimal palatal stiffening. CONCLUSION/SIGNIFICANCE: Injection Snoreplasty is a simple, safe, and effective office treatment for primary snoring. Advantages over current snoring procedures include simplicity, low cost, decreased posttreatment pain levels, and minimal/no convalescence.

Adult↗

Temperature-controlled radiofrequency tissue volume reduction of the soft palate (somnoplasty) in the treatment of habitual snoring: results of a European multicenter trial.

Temperature-controlled radiofrequency tissue volume reduction of the soft palate has been introduced as a minimally invasive, outpatient procedure for the treatment of habitual snoring and mild obstructive sleep apnea. A prospective, non-randomized multi-center European clinical study was conducted to investigate the efficacy of Somnoplasty in reducing snoring. Each patient underwent a pre- and post-treatment full-night polysomnography. TCRFe of the soft palate (1 midline lesion/session) was carried out under local anesthesia with a maximum of 3 consecutive treatment sessions. Forty-five, nonapneic snorers (RDI 5.1 +/- 4.3, BMI 26.6 +/- 3.2 kg/m2) completed the protocol. A mean of 692.3 +/- 67.7) J was delivered/treatment session. There was a significant improvement in the snoring index 7.6 (+/- 2.1 ) vs 4.1 (+/- 2.9). p < 0.001 and in the Epworth Sleepiness Score 8.5 (+/- 5.0) versus 6.0 (+/- 4.3), p = 0.001. No major adverse events were reported and postoperative pain was minimal. Overall, 45% of patients had a post-treatment snoring index < 3 (success) and 84% of the patients reported an improvement in snoring. It was concluded that Somnoplasty, following a protocol with I midline lesion of maximal 700 J/lesion for 1-3 treatment sessions, improves snoring in the majority of patients. Further studies are required to investigate whether treatment efficacy can be improved by utilizing multiple lesions/session or by increasing the amount of energy/lesion. The absence of serious adverse events and the findings of minimal postoperative pain support the use of TCRFe (Somnoplasty) as a minimally invasive surgical procedure for snoring.

Adult↗

Swallowing dysfunction related to snoring: a videoradiographic study.

Biopsy studies of the soft palatal and oropharyngeal tissues in habitual snorers and patients suffering from obstructive sleep apnoea have shown signs of neurogenic lesions. These lesions might affect the pharyngeal swallowing function, which is dependent on adequate sensitivity. The objective of the present study was to test the hypothesis that snoring is associated with aberrant pharyngeal swallowing function. Forty-one consecutive patients without dysphagia, seeking medical attention because of heavy snoring and various degrees of daytime sleepiness, were prospectively selected. Fifteen non-snoring volunteers without dysphagia served as controls. Patients and volunteers were videoradiographically examined in lateral and posteroanterior views during the oral and pharyngeal phases of swallowing. The hypothesis was verified. Snoring patients demonstrated deviant pharyngeal swallowing function seven times more frequently than did the non-snoring volunteers. Deviant pharyngeal swallowing function was observed in 22 (54%) of the snorers compared with 1 (7%) of the non-snoring volunteers. Impaired bolus control with premature leakage of bolus into the pharynx and a delayed evocation of the swallowing reflex was the most common finding, followed by bolus residual in the pharynx and laryngeal penetration. The conclusion was that snoring is associated with subclinical pharyngeal swallowing dysfunction.

Adult↗

Palatal implants: a new method for the treatment of snoring.

OBJECTIVE: To evaluate the safety, feasibility and effectiveness of a treatment for snoring using permanent palatal implants. MATERIAL AND METHODS: This was a prospective, non-randomized study involving 35 healthy patients (26 males, 9 females) referred for treatment of habitual snoring. A baseline medical examination, an evaluation of snoring-related subjective symptoms and an overnight sleep analysis were performed. Three PET implants were placed in the palate of each patient using a new delivery device under local anaesthesia. The patients were followed by means of office visits at 2-3, 14, 30 and 90 days postoperatively, at which discomfort, pain, adverse events and changes in snoring-related parameters were recorded. RESULTS: The average time required for the procedure was 8 min; 23% of the patients required no postoperative analgesia; the average consumption of analgesic was 125 mg of diclofenac and the average duration of analgesia was 1.5 days after the procedure. No bleeding, haematoma or infection were observed. Two of the implants were extruded; both of these patients experienced a satisfactory reduction in snoring intensity and no replacements were necessary. The mean reduction in snoring intensity was 51%, with the visual analogue scale score evaluated by the bed partner falling from 7.3 to 3.6 (p<0.001). The Epworth Sleepiness Score dropped from 9.3 to 4.6 (p<0.001). In total, 86% of the bed partners and 89% of the patients recommended the procedure. CONCLUSION: The new palatal implant system is safe and is associated with low morbidity. It is a fast, simple and effective treatment for snoring.

Adult↗

Oral appliances for the management of severe snoring: a randomized controlled trial.

The aim of this randomized controlled trial was to assess the effectiveness of a mandibular advancement appliance (MAA) in managing severe snoring. Twenty-eight adults with severe snoring and normal overnight oximetry were recruited from sleep disorder clinics. A maxillary placebo appliance and a MAA were worn by each subject for a period of 4-6 weeks each. Questionnaires at baseline and after each appliance period assessed bed partners' reports of snoring severity (loudness and number of nights per week), and patients' records of daytime sleepiness. Twenty-five subjects completed the entire trial. The MAA was significantly more effective than the placebo in reducing the frequency and loudness of snoring, the reported daytime sleepiness and the frequency of morning tiredness. Excessive salivation was the most commonly reported complication. It was concluded that the custom-made MAA was significantly more effective than the placebo in managing the main symptoms of severe snoring. However, not all subjects' partners reported an improvement with the MAA, with 84 per cent reporting a reduction in snoring loudness and 76 per cent reporting snoring on fewer nights per week.

Adult↗

Comparison of self- and spouse reports of snoring and other symptoms associated with sleep apnea syndrome.

We compared self- and spouse reports of snoring and other symptoms of sleep apnea syndrome ascertained from married couples in a community-based survey. Agreement between the two types of report varied between 70-98%, but was modest (kappa = -0.01-0.52) when adjusted for chance. For men, spouse reports yielded higher prevalence rates for snoring and for four other symptoms. For women, estimates of symptom prevalence were consistently lower by spouse report than by self-report. In multivariate analyses, the effect on snoring of gender and obesity increased and of age decreased when spouse reports were compared to self-reports. Snoring, according to spouse reports, was a significant risk factor for ischemic heart disease, but snoring according to self-reports showed a smaller effect and was not statistically significant. Snoring was not associated with hypertension when defined by either self- or spouse report. These observations suggest that questionnaire data of snoring and other symptoms of sleep apnea syndrome may be misclassified in part, and that such misclassification can affect estimates of prevalence and effects.

Adult↗

Cardiorespiratory and autonomic interactions during snoring related resistive breathing.

STUDY OBJECTIVES: We hypothesized that blood pressure (BP) is less during snoring as compared to periods of non-snoring in non-apneic individuals. Furthermore, we hypothesized that this reduction may be accompanied by a simultaneous decrease in sympathetic (SNSA) and parasympathetic (PNSA) nervous system activity and an increase in heart rate (HR). DESIGN: N/A. SETTING: N/A. PATIENTS OR PARTICIPANTS: N/A. MEASUREMENTS: The variables mentioned above in addition to breathing frequency were measured in 9 subjects during NREM sleep. In addition, the lowest systolic (SBP) and diastolic blood pressure (DBP) during inspiration and the highest SBP and DBP during expiration was determined breath-by-breath from segments selected from each NREM cycle. Heart rate variability was used as a marker of autonomic nervous system activity. RESULTS: Our results showed that BP during snoring decreased compared to non-snoring and the breath-by-breath BP analysis suggested that this difference may have been mediated by changes in intrathoracic pressure. In conjunction with the decrease in BP, SNSA decreased and HR increased however PNSA remained constant. Thus, a decrease in PNSA was likely not the primary mechanism responsible for the HR response. CONCLUSIONS: We conclude that BP responses and SNSA during snoring are similar to that reported previously in non-snoring individuals. However, the causal mechanisms maybe different and manifested in other measures such as HR. Thus, nocturnal cardiovascular and autonomic function maybe uniquely different in non-apneic snoring individuals.

Adult↗