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Dynamic CO2 for Obstructive Sleep Apnea

N/A

Recruiting

Led By Scott Sands, PhD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 night

Awards & highlights

Study Summary

This trial tests a new model of OSA, which may lead to better treatments for a disorder with major consequences for heart, brain and risk of accidents.

Who is the study for?

This trial is for adults with diagnosed or suspected obstructive sleep apnea (OSA) who are not currently experiencing unstable medical conditions. Participants should be using CPAP or similar treatments but can withhold them for 3 days before study visits. Those with a highly-sensitive gag reflex, severe claustrophobia, recent cardiovascular events, on certain medications like opioids, or pregnant/nursing women cannot join.Check my eligibility

What is being tested?

The study tests whether precise CO2 delivery during sleep can prevent the onset of OSA respiratory events in patients with 'drive-dependent' OSA. It compares the effects of dynamic CO2 versus sham (fake) CO2 to see if increasing ventilatory drive helps maintain breathing and muscle activity in the throat.See study design

What are the potential side effects?

While specific side effects are not listed, participants may experience discomfort due to esophageal catheter placement and intramuscular electrodes. There could also be risks associated with brief exposure to hypercapnic-hypoxic gas mixtures used in this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 night

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 night

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 night for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduction in odds of respiratory event

Secondary outcome measures

Increase in peak genioglossus muscle activity

Increase in peak genioglossus muscle activity per unit increase in ventilatory drive

Increase in ventilation

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Dynamic CO2 within Drive-Dependent OSAExperimental Treatment1 Intervention

During sleep, before ~30 distinct respiratory events, we will administer ~2% CO2 for ~3-4 breaths.

Group II: Dynamic CO2 within Classic OSAActive Control1 Intervention

During sleep, before ~30 distinct respiratory events, we will administer ~2% CO2 for ~3-4 breaths.

Group III: Sham CO2 within Drive-Dependent OSAPlacebo Group1 Intervention

During sleep, Sham CO2 (air) will be administered for ~3-4 breaths before respiratory events.

Group IV: Sham CO2 within Classic OSAPlacebo Group1 Intervention

During sleep, Sham CO2 (air) will be administered for ~3-4 breaths before respiratory events.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,615 Previous Clinical Trials

11,470,794 Total Patients Enrolled

Dillon GilbertsonStudy DirectorBrigham and Women's Hospital and Harvard Medical School

2 Previous Clinical Trials

61 Total Patients Enrolled

Scott Sands, PhDPrincipal InvestigatorBrigham and Women's Hospital and Harvard Medical School

1 Previous Clinical Trials

36 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are younger individuals below 45 years of age eligible for this trial?

"This trial is recruiting participants aged 21 and over but below 80 years of age."

Answered by AI

Do I fulfill the criteria to take part in this medical experiment?

"Requirements for joining this clinical trial are a diagnosis of obstructive sleep apnea and being between the ages of 21 to 80 years old. A total of 36 potential participants will be accepted into the study."

Answered by AI

Is this experimental protocol currently seeking participants?

"According to the data provided on clinicaltrials.gov, this specific trial is not presently enrolling patients; it was first posted on November 1st 2023 and last updated October 16th of that same year. Fortunately, there are 171 other medical studies actively looking for participants as we speak."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reversible Effect of Falling Ventilatory Drive in Drive-dependent OSA

Scott Aaron Sands 2024. "Reversible Effect of Falling Ventilatory Drive in Drive-dependent OSA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06091098.