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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

Must not have

Current unstable angina

Severe respiratory, neurological, liver and renal diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 days to 30 days

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am a veteran prescribed opioids.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have ongoing chest pain or discomfort.

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I do not have severe lung, brain, liver, or kidney diseases.

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I am currently taking tramadol and suboxone/buprenorphine.

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I have ongoing seizures that aren't controlled.

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I do not have any untreated heart conditions, including recent heart attacks or surgeries.

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I have heart failure with specific breathing patterns.

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I have schizophrenia that has not been treated.

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I have had a stroke recently.

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I have had a traumatic brain injury.

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I have a serious sleep disorder like narcolepsy.

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I have hypothyroidism that has not been treated.

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My BMI is over 40.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Apneic threshold- a measure of breathing instability

Carbon -dioxide reserve

Cerebrovascular responsiveness to carbon-dioxide

+1 more

Secondary study objectives

Apnea hypopnea index

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3030

0 / 13Eligibility criteria met