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Poor adherence to continuous positive airway pressure (CPAP) commonly affects therapeutic response in obstructive sleep apnea (OSA). We aimed to determine predictors of adherence to CPAP among participants of the Sleep Apnea and cardioVascular Endpoints (SAVE) trial. SAVE was an international, randomized, open trial of CPAP plus usual care versus usual care (UC) alone in participants (45-75 years) with co-occurring moderate-to-severe OSA (≥12 episodes/h of ≥4% oxygen desaturation) and established cardiovascular (CV) disease. Baseline sociodemographic, health and lifestyle factors, OSA symptoms, and 1-month change in daytime sleepiness, as well as CPAP side effects and adherence (during sham screening, titration week, and in the first month), were entered in univariate linear regression analyses to identify predictors of CPAP adherence at 24 months. Variables with p <0.2 were assessed for inclusion in a multivariate linear mixed model with country, age, and sex included a priori and site as a random effect. Significant univariate predictors of adherence at 24 months in 1,121 participants included: early adherence measures, improvement in daytime sleepiness at 1 month, fixed CPAP pressure, some measures of OSA severity, cardiovascular disease history, breathing pauses, and very loud snoring. While observed adherence varied between countries, adherence during sham screening, initial titration, and the first month of treatment retained independent predictive value in the multivariate model along with fixed CPAP pressure and very loud snoring. Early CPAP adherence had the greatest predictive value for identifying those at highest risk of non-adherence to long-term CPAP therapy. SAVE is registered with clinicaltrials.gov (NCT00738179).

The efficacy of immediate adaptation of mandibular advancement devices made of thermoplastic material as a treatment option for sleep-disordered breathing (SDB) has been demonstrated in clinical studies. To date, there have been no studies comparing the efficacy of such prefabricated devices with custom-made devices. Our purpose was to compare the efficacy of both types of devices in patients with SDB. A randomized controlled cross-over trial, comprising 4 months of treatment with a thermoplastic and a custom-made device, with a 1-month washout interval. A total of 35 patients (29 males; age, 49 +/- 9 yr; apnea-hypopnea index [AHI], 13 +/- 11 events/h; body mass index, 28 +/- 4 kg/m(2)) completed the protocol. AHI was only reduced with the custom-made device (P = 0.005). In addition, this device reduced snoring to a greater extent than the thermoplastic device. The success rate was higher with the custom-made device (60 vs. 31%; P = 0.02). One-third of the patients demonstrated compliance failure with the thermoplastic device, mainly because of insufficient overnight retention. Total failure rate with the thermoplastic device was 69%, whereas the majority (63%) of these were successfully treated with the custom-made device. At the end of the study, 82% of the patients preferred the custom-made device, and 9% had no preference (P < 0.0001). In this study, a custom-made device turned out to be more effective than a thermoplastic device in the treatment of SDB. Our results suggest that the thermoplastic device cannot be recommended as a therapeutic option nor can it be used as a screening tool to find good candidates for mandibular advancement therapy.

Purpose The effect of mandibular advancement device therapy on daytime sleepiness remains unclear. Here, we evaluate the effect of a mandibular advancement device on daytime sleepiness using the Karolinska Sleepiness Scale. Methods We randomized 88 snoring patients with an apnea-hypopnea index < 30 and daytime sleepiness to a mandibular advancement device or a sham device for four months. The Karolinska Sleepiness Scale, which measures grades of sleepiness from 1 (very alert) to 9 (very sleepy), was used for seven consecutive days, four times each day. The results were analyzed with quantile regression at quartiles controlling for baseline, age, body mass index (kg/m 2 ), sex, apnea-hypopnea index, and full-time work. Results The Karolinska Sleepiness Scale score was lower with the mandibular advancement device than with the sham device at specific time intervals. The positive effect of mandibular advancement device therapy occurred at wake up and before lunch during the whole week and before lunch on weekdays at the middle quartile. The adjusted differences between the interventions favored mandibular advancement device therapy by almost one unit and normalized the Karolinska Sleepiness Scale scores at wake up and before lunch. In addition, there were positive effects of mandibular advancement device therapy before dinner at the highest quartile during the whole week, on weekdays, and on the weekend. Conclusion Mandibular advancement devices used for snoring and sleep apnea reduce daytime sleepiness, particularly at wake up and before lunch, but provide some benefit before dinner.

Objective A preliminary clinical evaluation of the efficacy, comfort, and adverse reactions of two mandibular advancement devices (MADs) in the treatment of Obstructive Sleep Apnea (OSA). Methods Forty patients with mild-to-severe OSA were recruited and randomly divided into two groups. They were treated with Shark-fin or Silensor MAD, respectively. Treatment efficacy was evaluated by home sleep apnea tests, the snoring scale, Epworth Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index (PSQI). A comfort scale questionnaire was applied. Cone beam computed tomography (CBCT), cephalometric radiography, and intraoral scanning were made before and after 3-month treatment to detect temporomandibular joints (TMJ), dental and skeletal changes. All data were assessed as normal distributed and analyzed by t test. The significance level was defined as α = 0.05. Results The effective rate, defined as a decrease in Respiratory Event Index (REI) to less than 5 events per hour or a decrease of more than 50%, was 70% in the Shark-fin MAD group and 50% in the Silensor MAD group. REI, lowest oxygen saturation and maximum apnea and hypoventilation time were significantly improved in Shark-fin MAD group ( P  < 0.01), and the proportion of non-rapid eye movement (REM) sleep stage 3 was higher than before use ( P  < 0.05), while only REI and lowest oxygen saturation were significantly improved in Silensor MAD group ( P  < 0.05). The loudness of snoring was significantly decreased after one day using Shark-fin MAD ( P  < 0.05), and further decreased after one month ( P  < 0.01). Conversely, Silensor MAD exhibited inferior efficacy in mitigating snoring compared to Shark-fin MAD. Upon wearing the Shark-fin MAD, ESS were significantly improved after one month and three months ( P  < 0.05), and PSQI improved after three months ( P  < 0.05). Additionally, the Shark-fin MAD group had a significantly better comfort score compared to the Silensor MAD group ( P  < 0.05). There was no significant difference in TMJ, dental and skeletal structures in the two groups before and after treatment ( P  > 0.05). Conclusion Both two MADs were effective in reducing REI and increasing lowest oxygen saturation on OSA patients, and Shark-fin MAD has better improvement effect and faster onset of action. In addition, Shark-fin MAD was superior to Silensor MAD in improving snoring loudness, daytime sleepiness, sleep quality and wearing comfort. There were no significant dental or skeletal changes, and no alterations in occlusion or temporomandibular joint function in the short term. Trial registration Clinical Trials.gov Registration ID ChiCTR2400086628. Registered 08/07/ 2024-Retrospectively registered , https://register.clinicaltrials.gov .

Objectives This study aimed to assess possible dental side effects associated with long-term use of an adjustable oral appliance compared with continuous positive airway pressure (CPAP) in patients with the obstructive sleep apnea syndrome and to study the relationship between these possible side effects and the degree of mandibular protrusion associated with oral appliance therapy. Materials and methods As part of a previously conducted RCT, 51 patients were randomized to oral appliance therapy and 52 patients to CPAP therapy. At baseline and after a 2-year follow-up, dental plaster study models in full occlusion were obtained which were thereupon analyzed with respect to relevant variables. Results Long-term use of an oral appliance resulted in small but significant dental changes compared with CPAP. In the oral appliance group, overbite and overjet decreased 1.2 (±1.1) mm and 1.5 (±1.5) mm, respectively. Furthermore, we found a significantly larger anterior–posterior change in the occlusion (−1.3 ± 1.5 mm) in the oral appliance group compared to the CPAP group (−0.1 ± 0.6 mm). Moreover, both groups showed a significant decrease in number of occlusal contact points in the (pre)molar region. Linear regression analysis revealed that the decrease in overbite was associated with the mean mandibular protrusion during follow-up [regression coefficient ( β ) = −0.02, 95 % confidence interval (−0.04 to −0.00)]. Conclusions Oral appliance therapy should be considered as a lifelong treatment, and there is a risk of dental side effects to occur. Clinical relevance Patients treated with the oral appliance need a thorough follow-up by a dentist or dental-specialist experienced in the field of dental sleep medicine.

Purpose Although not a disease, primary snoring often leads to social problems. In an earlier retrospective pilot study, we found hints that individuals were snoring less in a lateral versus a supine head position. The aim of this study is to elucidate on the effect of an anti-snoring pillow which changes the head position. Methods We designed an interventional, controlled, and randomized crossover study. It included 22 participants, between 18 and 78 years, who snored, had a BMI ≤ 30, and a sleep partner. Obstructive sleep apnea was ruled out by polysomnography (PSG) or by respiratory polygraphy (PG). Two potential participants dropped out. The first two phases were done at home (4 weeks in total), followed by two nights of polysomnography in our sleep laboratory. During all phases, questionnaires regarding snoring, sleep quality, and pillow tolerance were completed by the patients and, as relevant, by their partners. Results The PSG parameters revealed a significant reduction in the snoring index ( p  = 0.03) when on the activated pillow without a deterioration in other respiratory parameters. This correlated well with the visual analog scale (VAS) that showed a significant decrease in snoring with the activated pillow according to the bed partners ( p  < 0.001). Subjective acceptance of the pillow during the study period was 100%. Conclusions This study shows that by using a pillow to change the head position, it is possible to reduce both subjective and objective snoring severity. German Clinical Trial Number: DRKS 00008744 and ethics commission registry number registry number 2013-406 M-MA

The aim of the study was to assess the influence of four mandibular protrusion positions, at a constant vertical dimension, on obstructive sleep apnea (OSA). Seventeen OSA patients (49.2 ± 8.5 years) received an adjustable mandibular advancement device (MAD). The patients underwent four polysomnographic recordings with their MAD in situ at, in random order, 0%, 25%, 50%, and 75% of the maximum protrusion. The mean apnea–hypopnea index (AHI) values of the patients differed significantly between the protrusion positions ( P  < 0.000). The 25% protrusion position resulted in a significant reduction of the AHI with respect to the 0% position, while in the 50% and 75% positions, even lower AHI values were found. The number of side effects was larger starting at the 50% protrusion position. We therefore recommend coming to a weighted compromise between efficacy and side effects by starting a MAD treatment in the 50% protrusion position.

The efficacy of occlusal splints in diminishing muscle activity and tooth-grinding damage remains controversial. The objective of this study was to compare the efficacy and safety of an occlusal splint (OS) vs. a palatal control device (PCD). Nine subjects with sleep bruxism (SB) participated in this randomized study. Sleep laboratory recordings were made on the second night to establish baseline data. Patients then wore each of the splints in the sleep laboratory for recording nights three and four, two weeks apart, according to a crossover design. A statistically significant reduction in the number of SB episodes per hour (decrease of 41%, p = 0.05) and SB bursts per hour (decrease of 40%, p < 0.05) was observed with the two devices. Both oral devices also showed 50% fewer episodes with grinding noise (p = 0.06). No difference was observed between the devices. Moreover, no changes in respiratory variables were observed. Both devices reduced muscle activity associated with SB.

Commentary In this clinical trial, Marklund and colleagues focused on a difficult group of patients-those who only snore or suffer from mild to moderate OSA but who also have impaired daytime performance and excessive daytime sleepiness. In this study, compliance was only assessed subjectively by questionnaires and not objectively. [...]it was not possible to study the relationship between compliance and efficacy of MAD therapy.

Purpose We performed a pilot study to determine whether nasal continuous positive airway pressure (CPAP) alleviates the symptoms of veterans with Gulf War illness (GWI) and sleep disordered breathing (SDB). Methods Eighteen male veterans with GWI and SDB recruited by advertisement, participated in a randomized, single-masked, sham-controlled treatment trial. Participants received 3 weeks of treatment during sleep with either therapeutic nasal CPAP or sham nasal CPAP. Using validated questionnaires, pain, fatigue, cognitive function, sleep disturbance, and general health were assessed by self-report before and after treatment. One of the participants assigned to therapeutic CPAP was excluded from the trial before starting treatment, leaving 17 participants. Results Compared to the nine sham nasal CPAP recipients, the eight participants receiving therapeutic nasal CPAP experienced improvements in pain (34%; p  = 0.0008), fatigue (38%; p  = 0.0002), cognitive function (33%; p  = 0.004), sleep quality (41%; p  = 0.0003), physical health (34%; p  = 0.0003), and mental health (16%; p  = 0.03). Conclusions Our findings in this pilot study suggest that nasal CPAP may greatly improve symptoms in veterans with GWI and SDB.