Actively Recruiting

Phase Not Applicable
Age: 21Years - 80Years
All Genders
NCT06091098

Reversible Effect of Falling Ventilatory Drive in Drive-dependent OSA

Led by Brigham and Women's Hospital · Updated on 2025-03-19

36

Participants Needed

1

Research Sites

196 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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 (OSA) with AHI 65 events/hour reported within the past year or suspected OSA based on symptoms like snoring, sleepiness, or witnessed apneas
  • Use of CPAP or other therapies is allowed; participants must withhold treatment for 3 days before each study visit unless they are occupational drivers or operate heavy machinery
Not Eligible

You will not qualify if you...

  • Any unstable medical conditions
  • Heart failure with known left ventricular ejection fraction (LVEF) less than 45%, recent cardiovascular or cerebrovascular event within the past 12 months
  • Medications that depress ventilatory drive such as opioids or barbiturates
  • Conditions increasing sleep arousability like insomnia
  • Other sleep disorders complicating sleep assessment including 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, including frequent gagging when brushing teeth
  • Use of aspirin or other oral anti-platelets or anticoagulants if intramuscular electrodes are used
  • Severe claustrophobia preventing use of oronasal mask
  • Pregnancy or nursing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

S

Scott Sands, PhD

CONTACT

A

Atqiya Aishah, PhD

CONTACT

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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