What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Oxygen therapy for sleep apnea can improve oxygenation and reduce hypoxia, but potential side effects include nasal dryness, nosebleeds, and, in rare cases, oxygen toxicity. Finasteride, a 5-alpha-reductase inhibitor, is primarily used for benign prostatic hyperplasia and can cause sexual dysfunction, including decreased libido, erectile dysfunction, and ejaculation disorders. Acetazolamide, a carbonic anhydrase inhibitor, is used to affect respiratory drive and can lead to side effects such as tingling in the extremities, frequent urination, taste alterations, and, less commonly, metabolic acidosis.

What prior FDA approvals exist?

The FDA has approved several treatments for sleep apnea, primarily focusing on improving oxygenation and reducing hypoxia. Continuous Positive Airway Pressure (CPAP) therapy is the most common and effective treatment, providing a steady stream of air to keep airways open. While Finasteride, a 5-alpha-reductase inhibitor, is not typically used for sleep apnea, it is approved for benign prostatic hyperplasia and male pattern baldness. Acetazolamide, a carbonic anhydrase inhibitor, is approved for conditions like glaucoma and altitude sickness and has shown promise in improving respiratory drive in sleep apnea patients. However, its use for sleep apnea is not yet FDA-approved.

What other types of research exist?

Promising novel alternatives for treating sleep apnea in 2024 include: 1) Hypoglossal nerve stimulation, which improves airway patency by stimulating the muscles of the tongue. 2) Myo-activated oral appliances that adjust the position of the jaw and tongue to keep the airway open. 3) Pharmacological agents like solriamfetol, which promotes wakefulness and reduces excessive daytime sleepiness. 4) Emerging therapies targeting the orexin system, such as orexin receptor antagonists, which may help regulate sleep-wake cycles and improve sleep quality.

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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

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I am 60 or older with mild to moderate sleep apnea.

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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:

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I have severe sleep apnea.

Select...

I have a history of prostate cancer.

Select...

I am a male diagnosed with low testosterone.

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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.

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I have a seizure disorder.

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I have kidney or liver problems.

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I have a serious lung condition and need extra oxygen or have low oxygen levels.

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I am not using certain medications or substances that affect my nervous system.

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My BMI is over 34.

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

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

0 / 13Eligibility criteria met

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.