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Reversible Effect of Falling Ventilatory Drive in Drive-dependent OSA

ConditionOSA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorBrigham and Women's Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dynamic CO2

    Other intervention

    2% inspired CO2 for 2-4 breaths

  • Sham CO2

    Other intervention

    Air

Treatment groups

36 Participants
are divided into 4 treatment groups
Group A: Dynamic CO2 within Drive-Dependent OSAExperimental treatment 1 intervention
Group B: Dynamic CO2 within Classic OSAActive comparator 1 intervention
Group C: Sham CO2 within Drive-Dependent OSASham comparator 1 intervention
Group D: Sham CO2 within Classic OSASham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Reduction in odds of respiratory event

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

Time frame
1 night

Secondary outcomes

1

Reduction in odds of respiratory event per unit increase in ventilatory drive

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

Time frame
1 night
2

Increase in ventilation

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

Time frame
1 night
3

Increase in ventilation per unit increase in ventilatory drive

Difference between drive-dependent OSA and classic OSA subgroups

Time frame
1 night
4

Increase in peak genioglossus muscle activity

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

Time frame
1 night

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov
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