Randomized Trial of 2 Self-Titrated Oral Appliances for Airway Management

2020 ◽  
pp. 002203452095697
Author(s):  
E. Schneiderman ◽  
P. Schramm ◽  
J. Hui ◽  
P. D. Wilson ◽  
P. Moura ◽  
...  
Keyword(s):  
Crossover Trial ◽  
Positive Airway Pressure ◽  
Mouth Opening ◽  
Oral Appliance ◽  
Oral Appliances ◽  
Pressure Therapy ◽  
Randomized Crossover Trial ◽  
Obstructive Sleep ◽  
Respiratory Event ◽  
Test Population

The effectiveness and predictability of 2 different oral appliance (OA) designs to reduce the respiratory event index (REI) in moderate and severe obstructive sleep apnea (OSA) patients requires elucidation. The primary aim of the trial was to determine if 2 widely used midline-traction and bilateral-thrust OA designs differ in effectiveness to reduce the REI within a single test population categorized by OSA severity. Moderate and severe adult OSA patients, who were previously prescribed continuous positive airway pressure therapy (CPAP) but were dissatisfied with it ( n = 56), were studied by home-polygraphy in a randomized crossover trial using either midline-traction with restricted mouth opening (MR) or bilateral thrust with opening permitted (BP) design OAs. OAs were used nightly for 4 wk (T2) followed by a 1-wk washout period, then 4 wk (T4) using the alternate OA. REI and oxygen saturation (SaO2) were primary outcomes, while predictability and efficacy comparison of the 2 OAs were secondary outcomes. Thirty-six participants had used MR and BP OAs during both 4-wk study legs. Twenty (55.6%) MR OA-using participants, 25 (69.4%) BP OA-using participants, and 16 (44.4%) participants using both OAs had significant REI reductions. Overall baseline (T0) median REI (interquartile range) of 33.7 (20.7–54.9) was reduced to 18.0 (8.5–19.4) at T2 and to 12.5 (8.2–15.9) at T4 ( P < 0.001). Comparison of the 2 sequence groups’ (MR-BP and BP-MR) REI showed the median differences between T0 and T2 and T4 were highly significant ( P < 0.001). Regression analysis predicted about half of all users will have REIs between 8 and 16 after 2 mo. Baseline overjet measures >2.9 mm predicted greater OA advancement at T4. Mean and minimum SaO2 did not change significantly from T0 to T2 or T4. MR and BP OA designs similarly attenuated REI in moderate and severe OSA individuals who completed the 8-wk study protocol with greater REI reduction in those with severe OSA (ClinicalTrials.gov NCT03219034).

scholarly journals A Randomized Crossover Trial of a Pressure Relief Technology (SensAwake™) in Continuous Positive Airway Pressure to Treat Obstructive Sleep Apnea

2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Richard K. Bogan ◽  
Charles Wells
Keyword(s):  
Sleep Quality ◽  
Crossover Trial ◽  
Positive Airway Pressure ◽  
Pressure Relief ◽  
Quality Outcomes ◽  
Cpap Adherence ◽  
Randomized Crossover Trial ◽  
Obstructive Sleep ◽  
Cpap Devices

Objectives/Background. Improving adherence to CPAP devices is crucial to reduce the long-term morbidity associated with OSA. SensAwake is a unique pressure relief technology that aims to promptly reduce the pressure upon sensing irregular respiration indicative of wakefulness. The purpose of this study was to compare adherence and sleep-quality outcomes in patients treated by CPAP with and without SensAwake technology.Methods. Participants with moderate-to-severe OSA were randomized to use CPAP devices with or without SensAwake (4 weeks) before crossing over.Results. Sixty-five patients completed both arms of the trial. There were no statistically significant differences in CPAP adherence with or without SensAwake over the study period (SensAwake ON272.67±17.06versus SensAwake OFF289.09±15.24;p=0.180). SensAwake reported a significantly lower system leak, 90th percentile leak, and time spent with excessive (>60 L/min) leak. Subgroup analysis suggested a trend towards improved adherence in patients with moderate-to-severe insomnia when using SensAwake.Conclusions. Using SensAwake incurred benefit in terms of reduced leaks; however, SensAwake did not improve CPAP adherence or objective sleep quality. Further studies should investigate the accuracy of observed trends towards increased adherence using SensAwake among patients with OSA and insomnia.

Combined oral appliance and positive airway pressure therapy for obstructive sleep apnea: a pilot study

2010 ◽  
Vol 15 (2) ◽  
pp. 203-208 ◽  
Author(s):  
Ali A. El-Solh ◽  
Binusha Moitheennazima ◽  
Morohunfolu E. Akinnusi ◽  
Paul M. Churder ◽  
Anthony M. Lafornara
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Pilot Study ◽  
Airway Pressure ◽  
Positive Airway Pressure ◽  
Oral Appliance ◽  
Pressure Therapy ◽  
Positive Airway Pressure Therapy ◽  
Obstructive Sleep

scholarly journals Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons during Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy: A Prospective Randomized Crossover Trial

Medicina ◽  
2021 ◽  
Vol 57 (9) ◽  
pp. 915
Author(s):  
Yen-Lung Chen ◽  
Li-Pang Chuang ◽  
Shih-Wei Lin ◽  
Hung-Yu Huang ◽  
Geng-Hao Liu ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Continuous Positive Airway Pressure ◽  
Sleep Quality ◽  
Airway Pressure ◽  
Crossover Trial ◽  
Positive Airway Pressure ◽  
Cpap Therapy ◽  
Randomized Crossover Trial ◽  
Obstructive Sleep

Backgroundand Objectives: Obstructive sleep apnea (OSA) patients may remove their mask unconsciously during automatic continuous positive airway pressure (Auto-CPAP) therapy and therefore cannot receive good treatment. The discomfort from the airflow of Auto-CPAP may be one reason for interrupted sleep. Sens Awake (SA) can detect the arousal and lower the pressure to prevent patients from fully awakening from sleep. Materials and Methods: To evaluate the effect of SA, we designed a prospective, randomized, crossover trial comparing Auto-CPAP with and without SA on Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Nasal Obstruction Symptom Evaluation (NOSE) Scale and recorded data from the auto-CPAP machine. Results: In the 25 patients who completed the study, the gender, age, body mass index, neck circumference, polysomnography data, and previous CPAP use were not significantly different between the two arms. The average and 90th percentile pressures were significantly lower during SA on (SA on vs. off: 6.9 ± 2.7 vs. 7.3 ± 2.6 [p = 0.032] and 8.6 ± 3.0 vs. 9.2 ± 2.9 [p = 0.002], respectively). The time used, days used, compliance, average and 90th percentile leaks, and the residual Apnea-Hypopnea Index (AHI) were not significantly changed between the SA on-and-off. Based on the subjective evaluation, PSQI, ESS, and NOSE were not significantly different between the SA on-and-off; however, based on additional analyses which were compared with baseline data, the ESS was significantly lower when the SA was on (SA on vs. baseline: 11.1 ± 6.1 vs. 13.2 ± 6.0 [p = 0.023]). Conclusions: CPAP therapy with or without two weeks of the SA had a similar effect on CPAP use, sleep quality, daytime sleepiness, and nasal obstruction. The SA may have a tendency to improve daytime sleepiness, but needs further study with a longer duration of treatment.

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