Characterizing Upper Airway Collapse to Guide Patient Selection for Oral Appliance Therapy for Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT02489591|
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : March 9, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive||Device: Oral appliance Device: BluePro oral appliance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Characterizing Site and Severity of Upper Airway Collapse to Guide Patient Selection for Oral Appliance Therapy for Obstructive Sleep Apnea|
|Actual Study Start Date :||July 14, 2015|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||November 2018|
No Intervention: Control
No oral appliance (control) first, oral appliance (BluePro oral appliance or other device) second
Experimental: Oral appliance
oral appliance (BluePro oral appliance or other device) first, no oral appliance (control) second
Device: Oral appliance
Patients will bring their prescribed oral appliance.
Device: BluePro oral appliance
Patients without a prescribed oral appliance will have a device provided for the duration of the study (BluePro, BlueSom; used for investigational purposes only). The device provided is a prefabricated thermoplastic customizable mandibular advancement splint.
- Change in passive pharyngeal collapsibility (OA therapy minus control) [ Time Frame: 3 nights ]
The passive pressure-flow relationship is characterized by the critical closing pressure (Pcrit) , and the ventilatory flow at atmospheric pressure ( V passive). Pcrit and V passive will be determined using the standard 5-breath CPAP drop method.
The change in collapsibility will be compared across subgroups defined by the site of collapse measured using sleep-endoscopy. Patients will sleep supine for this measurement.
- Change in sleep apnea severity (AHI) [ Time Frame: 2 nights ]The change in apnea-hypopnea index (AHI, 3% desaturation or arousal criteria; OA therapy minus control) will be compared across subgroups defined by the site of collapse measured using sleep-endoscopy. Baseline collapsibility will be incorporated as a predictor of the change in AHI.
- Change in peak flow during sleep (OA therapy minus control) [ Time Frame: 2 nights ]During the portion of the night dedicated to measuring sleep apnea severity, peak flow will also be measured during sleep to quantify activated upper airway collapsibility.
- Objective sleep quality (OA therapy minus control) [ Time Frame: 2 nights ]Arousal index, one of the standard measures of sleep quality, will be assessed.
- Objective sleep quality (OA therapy minus control) [ Time Frame: 2 nights ]Proportion of sleep in Non rapid eyes movement ( NREM) stage 1,one of the standard measures of sleep quality, will be assessed.
- Subjective sleep quality (OA therapy minus control) [ Time Frame: 2 nights ]Patients will rate whether they slept better/worse/same with the OA vs control.
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|Ages Eligible for Study:||21 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with Obstructive Sleep Apnea
- Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
- Any medication known to influence breathing, sleep/arousal or muscle physiology
- Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
- Inability to sleep supine
- Periodontal disease and/or insufficient number of teeth
- Allergy to lidocaine or oxymetazoline hydrochloride
- For women: Pregnancy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489591
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||David A Wellman, PhD||Brigham and Women's Hospital|
|Responsible Party:||David Andrew Wellman, Director, Sleep Disordered Breathing Lab, Brigham and Women's Hospital, Brigham and Women's Hospital|
|Other Study ID Numbers:||
|First Posted:||July 3, 2015 Key Record Dates|
|Last Update Posted:||March 9, 2022|
|Last Verified:||February 2022|
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases