Your session is about to expire
← Back to Search
Other
Oxygen + Finasteride + Acetazolamide for Sleep Apnea in Elderly
Phase 4
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days to 30 days
Awards & highlights
Study Summary
This trial will test whether oxygen, finasteride, and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in the elderly via different mechanisms.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 60 or older with mild to moderate sleep apnea.
Select...
I am 60 or older with mild to moderate sleep apnea.
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
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 moreSecondary outcome measures
Apnea hypopnea index
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
Finasteride
1995
Completed Phase 4
~5940
Acetazolamide
2011
Completed Phase 4
~2910
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,353 Total Patients Enrolled
8 Trials studying Sleep Apnea
1,128 Patients Enrolled for Sleep Apnea
Susmita Chowdhuri, MDPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI
4 Previous Clinical Trials
600 Total Patients Enrolled
3 Trials studying Sleep Apnea
492 Patients Enrolled for Sleep Apnea
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received treatment for low thyroid hormone levels.I have a seizure disorder.I have kidney or liver problems.I am an elderly man eligible for the finasteride study.I have a history of serious heart conditions.I have a serious lung condition and need extra oxygen or have low oxygen levels.I am not using certain medications or substances that affect my nervous system.I have a history of prostate cancer.I have severe sleep apnea.I am a male diagnosed with low testosterone.My BMI is over 34.I have trouble walking or moving safely due to my age.I have been diagnosed with schizophrenia.You are allergic to finasteride or acetazolamide.I am 60 or older with mild to moderate sleep apnea.I am 60 or older with mild to moderate sleep apnea.I am an elderly man eligible for the finasteride study.
Research Study Groups:
This trial has the following groups:- Group 1: Acetazolamide (ACZ)
- Group 2: Hyperoxia
- Group 3: Finasteride
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Sleep Apnea Patient Testimony for trial: Trial Name: NCT02703220 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What have been the findings regarding potential risks of Hyperoxia/oxygen treatment?
"As Hyperoxia/oxygen is already approved, the safety of this drug has been assessed at a rating 3."
Answered by AI
To what extent do individuals aged eighty and above qualify for this research?
"For this particular research, individuals aged 60 to 89 are eligible for enrollment. In contrast, there are 43 clinical studies available for people under the age of majority and 222 for those above 65 years old."
Answered by AI
Who meets the prerequisites for participating in this research project?
"This trial is looking for 100 elderly individuals aged between 60 and 89 who have been clinically diagnosed with a sleep apnea syndrome. The participants must also meet other criteria, such as having an AHI of at least 5 to 20/hr with central, obstructive or mixed apneas and hypopneas. For the finasteride protocol only male seniors that satisfy these requirements can be enrolled in this study."
Answered by AI
Is this research endeavor presently seeking participants?
"Clinicaltrials.gov states that this particular research is still recruiting participants, with the initial posting dating back to July 3rd 2015 and last updated December 1st 2021."
Answered by AI
How many participants have been recruited for this trial thus far?
"Affirmative. The information hosted on clinicaltrials.gov affirms that this trial is presently seeking participants, which was initially posted on July 3rd 2015 and recently updated in December 2021. A total of 100 patients must be recruited from a single medical centre."
Answered by AI
What medical conditions are generally treated with Hyperoxia/oxygen?
"Hyperoxia/oxygen is prescribed to address metabolic alkalosis, salicylate intoxication, androgenetic alopecia, and benign prostatic hyperplasia."
Answered by AI
Who else is applying?
What state do they live in?
California
Michigan
New Jersey
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
John D. Dingell VA Medical Center, Detroit, MI
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I’ve been on a BiPAP for years and wake up completely exhausted and I’ve always wondered if oxygen or any other additional treatment would help me get a good night sleep.
I even purchased a SPO2 meter to prove to my pulmonologist that my O2 levels drop during the night.
PatientReceived 1 prior treatment
My CPAP is not working very well for me. When I ask the therapists at Kaiser about alternatives they they they have no patients that have used any. Do they rely on their patients for updates in apnea treatments.? They don't even offer the advice you can get from the internet.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
I live in San Francisco, do you expect to expand the trial to the San Francisco Bay Area ?
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Phone Call
Most responsive sites:
- John D. Dingell VA Medical Center, Detroit, MI: < 48 hours
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger