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Study for Drive-Dependent Obstructive Sleep Apnea (OSA)

This study is investigating a new approach to treat Obstructive Sleep Apnea (OSA), a common sleep disorder. Researchers are testing if giving small amounts of carbon dioxide (Dynamic CO2) for a few breaths can prevent breathing problems in people with a specific type of OSA called "drive-dependent OSA." They will compare this to a sham treatment (Sham CO2), which is just regular air. The study aims to see if reducing the odds of respiratory events (breathing problems) can be achieved in one night. You may be able to join if you are between 21 and 80 years old and have been diagnosed with OSA or have symptoms of OSA. The study is currently unclear on its recruitment status and plans to enroll 36 participants.

Study design
This is an interventional study with 36 participants, comparing the effects of Dynamic CO2 to Sham CO2. The study aims to understand how these interventions affect breathing in people with and without drive-dependent OSA.
What's involved
You will attend a virtual screening and consent visit, followed by a baseline sleep study. You will then have an overnight physiology study and a final overnight intervention study where carefully-timed CO2 stimulation will be performed. You will be asked to stop any OSA treatments for 3 days before each study visit.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, reduction in odds of respiratory event, is measured at one night.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06091098

Reversible Effect of Falling Ventilatory Drive in Drive-dependent OSA

Recruiting
NAAges 21–80InterventionalTreatment
Brigham and Women's Hospital
~36 participants
Updated 2025-03-19 on ClinicalTrials.gov
What's tested:Dynamic CO2Sham CO2

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduction in odds of respiratory event
Measured over 1 night

Conditions

OSA

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Scott Sands, PhD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital and Harvard Medical School
  • Dillon Gilbertson · STUDY_DIRECTOR · Brigham and Women's Hospital and Harvard Medical School

Who to contact

Scott Sands, PhD
[email protected]
8579280341
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

Any unstable medical conditions
Conditions that could meaningfully raise the cardiovascular risks of brief low-dose hypercapnic-hypoxic inspired gas mixture: heart failure (LVEF\<45% if known), recent cardiovascular event (\<12 mo), recent cerebrovascular event (\<12 mo)\*
Medications known to depress ventilatory drive (e.g. opioids, barbiturates)
Conditions likely to increase arousability from sleep: insomnia
Other sleep disorders that may complicate establishment of sleep: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias
For intramuscular electrodes and catheter: allergy to lidocaine
Highly-sensitive gag reflex. Patients with a self-reported 'highly-sensitive gag reflex', including an affirmative response to 'Do you sometimes gag when brushing your teeth?', will not take part in the physiology studies given the placement of an esophageal catheter
For intramuscular electrodes: use of aspirin or other oral anti-platelets / anti-coagulants
For oronasal mask: severe claustrophobia
Pregnancy or nursing
We do not intend to exclude patients with controlled cardiovascular disease (hypertension of any severity, arrhythmias, stents) common in the OSA patient population. The transient gas mixture interventions are mild, short-lived, and act to slow the spontaneous recovery of blood gas levels to prevent cyclic upper airway obstruction as opposed to exacerbating them. Control of breathing studies commonly increase inspired CO2/reduce inspired oxygen (using higher concentrations via rebreathing tests for longer durations) in patients with a range of comorbidities including heart failure. The level of hypercapnic-hypoxia used is equivalent to taking slightly smaller breaths (by about a third, for the standard dose gas mixture 2%CO2/18.5%O2) for several breaths, or skipping a breath (for the highest dose gas mixture 6%CO2/14%O2), physiological changes that typically cause no noticeable oxygen desaturation, and are minimal compared with the effects of the larger ventilation reduction that accompanies OSA.

What this trial measures

  • Reduction in odds of respiratory event1 night

    Active versus sham ventilatory drive intervention, difference between drive-dependent OSA and classic OSA subgroups