RECRUITING

Reversible Effect of Falling Ventilatory Drive in Drive-dependent OSA

Talk to us

Conditions

OSA

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Reversible Effect of Falling Ventilatory Drive in Drive-dependent OSA

Quick Facts

Study Start:2024-03-27
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06091098

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed OSA (AHI≥15 events/h reported in a PSG performed within 1 year) or Suspected OSA (snoring, sleepiness, witnessed apneas, other clinical symptoms)
  2. * 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.
  1. * Any unstable medical conditions
  2. * 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)\*
  3. * Medications known to depress ventilatory drive (e.g. opioids, barbiturates)
  4. * Conditions likely to increase arousability from sleep: insomnia
  5. * Other sleep disorders that may complicate establishment of sleep: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias
  6. * For intramuscular electrodes and catheter: allergy to lidocaine
  7. * 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
  8. * For intramuscular electrodes: use of aspirin or other oral anti-platelets / anti-coagulants
  9. * For oronasal mask: severe claustrophobia
  10. * Pregnancy or nursing
  11. * 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.

Contacts and Locations

Study Contact

Scott Sands, PhD
CONTACT
8579280341
sasands@bwh.harvard.edu
Atqiya Aishah, PhD
CONTACT
aaishah@bwh.harvard.edu

Principal Investigator

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

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-27
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-03-27
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • OSA