Actively Recruiting

Phase Not Applicable
Age: 21Years - 80Years
All Genders
ID06091098

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

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not 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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 virtual visit (video call) for screening and consent

Baseline Sleep Study

Duration - 1 day

Participants undergo a routine sleep study to confirm eligibility and establish baseline sleep characteristics.

1 overnight visit (in-person)

Overnight Physiology Study

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)

Overnight Intervention Study

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

Loading map...

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

Similar Trials

BREATH: Breakthrough Research in Electromyography for the As...

Obstructive Sleep Apnea (OSA)

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here