Actively Recruiting
Reversible Effect of Falling Ventilatory Drive in Drive-dependent Obstructive Sleep Apnea Using Timed Carbon Dioxide Delivery
Led by Brigham and Women's Hospital · Updated on 2025-03-19
36
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Obstructive sleep apnea (OSA) is a common condition that affects breathing during sleep and is linked to problems with heart health, brain function, daytime sleepiness, and quality of life. Traditional models do not fully explain OSA's complexity. Researchers are studying a newer model called drive-dependent OSA, where increased breathing drive helps prevent airway blockages. This study aims to show that preventing the loss of breathing drive can stop OSA events in people with drive-dependent OSA but not in those with classic OSA. The study involves carefully timed delivery of carbon dioxide (CO2) during sleep to keep the breathing drive from falling. Participants will undergo a series of sleep studies, including a baseline sleep study and an overnight physiological study to identify their OSA type. Then, during sleep, about 2% CO2 will be given for 3-4 breaths before about 30 respiratory events to see if it prevents OSA events. Sham treatments with air will be given as controls. The CO2 dose may be adjusted to a maximum of 6% or diluted to 1-1.5% if needed. The study compares effects between drive-dependent and classic OSA groups. Participants will join a virtual screening and consent visit followed by overnight sleep studies with advanced monitoring of ventilation, breathing drive, and muscle activity. Researchers will measure the reduction in likelihood of respiratory events, changes in ventilation, and muscle activity using detailed breath-by-breath analysis. The study lasts one night for each intervention, and results will be analyzed statistically to see if CO2 reduces OSA events specifically in drive-dependent OSA. Safety and event scoring follow current clinical guidelines.
CONDITIONS
Brief Title
Reversible Effect of Falling Ventilatory Drive in Drive-dependent OSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed obstructive sleep apnea with 15 or more events per hour reported in a sleep study within the past year, or suspected OSA with symptoms like snoring, sleepiness, or witnessed apneas
- Use of CPAP or other therapies is allowed; participants must be able to withhold treatment for 3 days before each study visit unless they operate heavy machinery or are occupational drivers
- Adults aged between 21 and 80 years
- Both men and women are eligible
You will not qualify if you...
- Any unstable medical conditions
- Heart failure with left ventricular ejection fraction less than 45% if known
- Recent cardiovascular or cerebrovascular event within the past 12 months
- Use of medications that depress ventilatory drive such as opioids or barbiturates
- Conditions likely to increase sleep arousals such as insomnia
- Other sleep disorders like periodic limb movements with arousal index over 10 per hour, narcolepsy, or parasomnias
- Allergy to lidocaine if intramuscular electrodes or catheter are used
- Highly sensitive gag reflex
- Use of aspirin or other oral blood thinners if intramuscular electrodes are used
- Severe claustrophobia preventing use of an oronasal mask
- Pregnancy or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 virtual visit (video call) for screening and consent
Duration - 1 day
Participants undergo a routine sleep study to confirm eligibility and establish baseline sleep characteristics.
1 overnight visit (in-person)
Duration - 1 night
Participants attend an overnight physiology study with gold standard measurements of ventilation, ventilatory drive, and dilator muscle activity to establish OSA phenotype.
1 overnight visit (in-person)
Duration - 1 night
Participants undergo an overnight study where carefully-timed inspired CO2 or sham air is administered during sleep to mitigate falling ventilatory drive and assess the reduction in respiratory events.
1 overnight visit (in-person)
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
S
Scott Sands, PhD
A
Atqiya Aishah, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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