← Back to Search

Other

Oxygen + Finasteride + Acetazolamide for Sleep Apnea in Elderly

Phase 4
Recruiting
Led By Susmita Chowdhuri, MD MS
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
Adults who are 60 years old and older, with mild to moderate sleep apnea with AHI >/=5 to 20/hr with central, obstructive, mixed apneas and hypopneas.
Adults who are 60 years old and older, with mild to moderate sleep apnea with AHI >/=5 to 20/hr with central, obstructive, mixed apneas and hypopneas
Must not have
Patients with severe sleep apnea (AHI>20/hr)
Patients with history of prostate cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days to 30 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing three treatments—oxygen, finasteride, and acetazolamide—to help elderly Veterans with sleep apnea. These treatments aim to make breathing more stable during sleep by providing extra oxygen, altering hormone levels, and changing how the body handles carbon dioxide. The goal is to find easier and more effective ways to treat sleep apnea in this group.

Who is the study for?
This trial is for elderly adults aged 60 and older with mild to moderate sleep apnea (AHI of 5-20/hr). It's specifically for men when testing finasteride. People with severe sleep apnea, prostate cancer, heart disease, schizophrenia, untreated thyroid issues, seizure disorders, kidney or liver problems can't join. Also excluded are those on certain medications or who use alcohol or tobacco.
What is being tested?
The study tests if oxygen therapy (hyperoxia), the drug finasteride, and acetazolamide can help reduce unstable breathing in elderly people with sleep apnea. The goal is to find new treatments that improve their quality of life by targeting different mechanisms causing the condition.
What are the potential side effects?
Possible side effects include allergic reactions to medications tested; finasteride may cause sexual dysfunction or mood changes; acetazolamide might lead to tingling sensations or fatigue; oxygen therapy could result in dry nasal passages.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 60 or older with mild to moderate sleep apnea.
Select...
I am 60 or older with mild to moderate sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe sleep apnea.
Select...
I have a history of prostate cancer.
Select...
I am a male diagnosed with low testosterone.
Select...
I have a history of serious heart conditions.
Select...
I have been diagnosed with schizophrenia.
Select...
I have not received treatment for low thyroid hormone levels.
Select...
I have a seizure disorder.
Select...
I have kidney or liver problems.
Select...
I have a serious lung condition and need extra oxygen or have low oxygen levels.
Select...
I am not using certain medications or substances that affect my nervous system.
Select...
My BMI is over 34.

Timeline

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

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment 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: FinasterideExperimental Treatment1 Intervention
Determine the effect of oral finasteride therapy vs placebo for 1 month on SDB and the AT and chemosensitivity during NREM sleep.
Group III: 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 7 days prior to the experimental night, on the night of the study and the subsequent night when polysomnography (PSG) will be performed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetazolamide
2011
Completed Phase 4
~3030
Finasteride
1995
Completed Phase 4
~6060

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Oxygen therapy improves oxygenation and reduces hypoxia by increasing the amount of oxygen available in the blood, which is crucial for patients with Sleep Apnea who experience frequent drops in blood oxygen levels. Finasteride, a 5-alpha-reductase inhibitor, affects hormonal pathways by reducing the conversion of testosterone to dihydrotestosterone (DHT), which may have indirect effects on sleep apnea through hormonal regulation. Acetazolamide, a carbonic anhydrase inhibitor, stimulates respiratory drive by causing metabolic acidosis, which in turn increases ventilation and helps reduce the frequency and severity of apneas. Understanding these mechanisms is important for Sleep Apnea patients as it highlights how different treatments can target various aspects of the condition to improve breathing and overall sleep quality.
Efficacy of pharmacotherapy for OSA in adults: A systematic review and network meta-analysis.The effect of acetazolamide on sleep apnea at high altitude: a systematic review and meta-analysis.Cerebral oxygenation in patients with OSA: effects of hypoxia at altitude and impact of acetazolamide.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,665 Previous Clinical Trials
3,765,714 Total Patients Enrolled
Susmita Chowdhuri, MD MSPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI
3 Previous Clinical Trials
508 Total Patients Enrolled
Susmita Chowdhuri, MDPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI
4 Previous Clinical Trials
600 Total Patients Enrolled

Media Library

Acetazolamide (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02703220 — Phase 4
Elderly Adults Research Study Groups: Acetazolamide (ACZ), Hyperoxia, Finasteride
Elderly Adults Clinical Trial 2023: Acetazolamide Highlights & Side Effects. Trial Name: NCT02703220 — Phase 4
Acetazolamide (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02703220 — Phase 4
Elderly Adults Patient Testimony for trial: Trial Name: NCT02703220 — Phase 4
~5 spots leftby Jul 2025