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Carbonic Anhydrase Inhibitor

Oxygen + Acetazolamide for Sleep Apnea (SDB Trial)

Phase 1 & 2

Recruiting

Led By Susmita Chowdhuri, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Veterans with prescription opioids

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 days to 30 days

Awards & highlights

SDB Trial Summary

This trial seeks to investigate how opioids cause sleep apnea & whether oxygen & acetazolamide can reduce it. Results could improve health of veterans with sleep apnea & opioid use.

Who is the study for?

This trial is for veterans aged 18-89 who are on prescription opioids and may have sleep issues like apnea due to their medication. It's not open to those with severe untreated mental or physical health conditions, recent strokes or heart problems, pregnant women, very high BMI (>40), or anyone unable to consent.Check my eligibility

What is being tested?

The study tests if oxygen (hyperoxia) and a drug called acetazolamide can help reduce irregular breathing and eliminate sleep apnea in people taking chronic opioid medications. It also looks at how these treatments affect life quality, sleep, and pain levels.See study design

What are the potential side effects?

Possible side effects of hyperoxia include dry throat or increased lung secretions. Acetazolamide may cause tingling sensations, diuresis (increased urine production), drowsiness, confusion, nausea, changes in taste sensation.

SDB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a veteran prescribed opioids.

SDB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 days to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 days to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days to 30 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Apneic threshold- a measure of breathing instability

Carbon -dioxide reserve

Cerebrovascular responsiveness to carbon-dioxide

+1 more

Secondary outcome measures

Apnea hypopnea index

SDB Trial Design

2Treatment groups

Experimental Treatment

Group I: HyperoxiaExperimental Treatment1 Intervention

Determine the effect of sustained hyperoxia overnight vs room air overnight on ventilatory control during sleep, including the apneic threshold, carbon-dioxide reserve and chemosensitivity measured via pressure support ventilation (PSV) during non-rapid eye movement sleep (NREM) sleep.

Group II: Acetazolamide (ACZ)Experimental Treatment1 Intervention

Determine the effect of acetazolamide on cerebrovascular responsiveness to CO2 during wake and sleep. Participants will receive oral ACZ therapy for 6 days, While on the medication following studies will be performed - experimental night study, experimental day study, polysomnography night study (PSG).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetazolamide

2011

Completed Phase 4

~2910

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,307,211 Total Patients Enrolled

8 Trials studying Sleep Apnea

1,078 Patients Enrolled for Sleep Apnea

John D. Dingell VA Medical CenterFED

8 Previous Clinical Trials

626 Total Patients Enrolled

1 Trials studying Sleep Apnea

100 Patients Enrolled for Sleep Apnea

Susmita Chowdhuri, MDPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI

4 Previous Clinical Trials

550 Total Patients Enrolled

3 Trials studying Sleep Apnea

442 Patients Enrolled for Sleep Apnea

Frequently Asked Questions

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

Does the eligibility criteria for this medical trial extend to geriatric populations?

"To be eligible for this trial, potential participants must have an age between 18 and 89. There are concurrently 60 trials available for those under 18 and 394 options for seniors over 65 years old."

Answered by AI

Are there any vacancies available for individuals wishing to join the trial?

"Affirmative. The clinicaltrials.gov repository reveals that this investigation, initially posted on May 2nd 2019, is actively searching for participants. A total of 150 people are required to be recruited from two different medical facilities."

Answered by AI

What is the overall participant count of this experiment?

"Affirmative. The information on clinicaltrials.gov states that this trial is currently in the process of patient recruitment, with an original post date of May 2nd 2019 and a recent update on October 24th 2022. Approximately 150 individuals are required across two sites for successful completion."

Answered by AI

Who has the opportunity to enroll in this scientific experiment?

"This trial requires 150 volunteer participants aged between 18 and 89 with a history of opioid use. Preference will be given to veterans that fit the same age range and have been prescribed opioids in the past."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sleep Disordered Breathing With Opioid Use

Susmita Chowdhuri 2019. "Sleep Disordered Breathing With Opioid Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05589753.

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