Reversible Effect of Falling Ventilatory Drive in Drive-dependent OSA

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Obstructive sleep apnea (OSA) is a highly prevalent disorder that has major consequences for cardiovascular health, neurocognitive function, risk of traffic accidents, daytime sleepiness, and quality of life. For years, a classic model of OSA has been used to describe the disorder, which fails to capture it's complexity. Recently, a model for OSA called drive-dependent OSA was discovered be more prevalent in the OSA population. The drive-dependent subgroup benefits exclusively from increased ventilation, increased dilator muscle activity, and reduced event risk when drive spontaneously rises. This study seeks to provide direct evidence that reducing the loss of drive prevents the loss of ventilation, pharyngeal muscle activity, and thus the onset of OSA respiratory events, specifically in drive-dependent but not classic OSA. This will be achieved using CO2 delivered at precise times during breaths in sleep to prevent loss of overall ventilatory drive.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• Diagnosed OSA (AHI≥15 events/h reported in a PSG performed within 1 year) or Suspected OSA (snoring, sleepiness, witnessed apneas, other clinical symptoms)

• Use of CPAP or other therapies is acceptable; individuals will be asked to withhold treatment for 3 days before each study visit. Individuals who are occupational drivers or operate heavy machinery will not be asked to withhold treatment.

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Scott Sands, PhD
sasands@bwh.harvard.edu
8579280341
Backup
Atqiya Aishah, PhD
aaishah@bwh.harvard.edu
Time Frame
Start Date: 2024-03-27
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 36
Treatments
Experimental: Dynamic CO2 within Drive-Dependent OSA
During sleep, before \~30 distinct respiratory events, we will administer \~2% CO2 for \~3-4 breaths.
Active_comparator: Dynamic CO2 within Classic OSA
During sleep, before \~30 distinct respiratory events, we will administer \~2% CO2 for \~3-4 breaths.
Sham_comparator: Sham CO2 within Drive-Dependent OSA
During sleep, Sham CO2 (air) will be administered for \~3-4 breaths before respiratory events.
Sham_comparator: Sham CO2 within Classic OSA
During sleep, Sham CO2 (air) will be administered for \~3-4 breaths before respiratory events.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital

This content was sourced from clinicaltrials.gov