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The Effect of Head Pitch and Roll Rotation Independent of Torso Rotation on the AHI in Positional Obstructive Sleep Apnea
This study evaluates the correlation of the position of the head during sleep, independent of the position of the torso, and the severity of apnea hypopneas in obstructive sleep apnea.
Obstructive Sleep Apnea (OSA) is a common diagnosis in the general population, with a prevalence in the United States of 3-7% in men and 2-5% in women. It is defined as a sleep-related breathing disorder that results in decreased or complete cessation of airflow while the patient has ongoing breathing effort. It is well documented that trunk position significantly affects the severity of OSA. In fact, 50-75% of individuals with a diagnosis of OSA show supine predominance or worsened apnea-hypopnea index (AHI) when sleeping in the supine position. Positional Obstructive Sleep Apnea (POSA) is defined as an AHI ≥5 with \>50% AHI reduction between the supine and non-supine positions and AHI. Studies show 49.5% of individuals with mild OSA (AHI 5-15), 19.4% with moderate OSA (AHI 15-30) and 6.5% in severe OSA (AHI \> 30) had POSA. Due to this high prevalence of POSA, especially in the mild and moderate OSA populations, positional therapies have been developed and researched. In this clinical trial, if only the head position is considered, all subjects are positional sensitive and OSA severity can be calculated and consistently minimized by limiting the allowable range of head roll angle during sleep. Ten subjects underwent a standard polysomnography with an additional head angle sensor and coached to fall asleep in various head positions. Torso position was changed between supine and non-supine for a given head roll angle epoch to show the OSA severity change with torso position. Each sleep epoch of unique head pitch and roll angle was scored individually for AHI and Oxygen Saturation (SPO2) de-saturation. Investigators hypothesize that specific head roll angles independent of torso position will significantly reduce AHI and SpO2 desaturation severity in patients. The primary aim is to determine the head roll angles that significantly improve POSA independent of torso position. By doing this, Investigators believe to identify a "safe zone" of head roll angles that improve POSA and that can be used to support the development of head positional therapy for POSA patients.
Age
21 - 60 years
Sex
ALL
Healthy Volunteers
Yes
Mass Lung and Allergy
Worcester, Massachusetts, United States
Start Date
November 28, 2016
Primary Completion Date
November 19, 2017
Completion Date
November 30, 2017
Last Updated
June 30, 2020
8
ACTUAL participants
Dual-axis inclinometer attached to the subject's forehead with tape
DEVICE
Lead Sponsor
Sleep Systems
Collaborators
NCT06430957
NCT07292922
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07225686