Sleep ApneaPhase 4NCT02703220
Sleep Apnea in Elderly
A Phase 4 study testing Hyperoxia/oxygen, Acetazolamide and Finasteride in people with Sleep Apnea and Elderly Adults, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Sleep-disordered breathing (SDB or sleep apnea) is very common among elderly Veterans and leads to increased morbidity and mortality in this population. The proposal aims to identity whether oxygen, finasteride and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in the elderly… Read more about this study
- Who is it for?
- Ages 60 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Elderly Adults
- What is being tested?
- Hyperoxia/oxygen, Acetazolamide and Finasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2015to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with mild to moderate sleep apnea with Apnea-Hypopnea Index (AHI)>/=5 to 20/hour with central, obstructive, mixed apneas and hypopneas
- For the finasteride protocol elderly men with above criteria will be enrolled
Who cannot join
- Patients with severe sleep apnea (Apnea-Hypopnea Index (AHI)>20/hour)
- Patients with history of prostate cancer
- Males with hypogonadism
- History of cardiac disease, including myocardial infarction
- Bypass surgery
- Atrial and ventricular tachy-bradycardias
Show all 27Show fewer
- Systolic congestive heart failure and Cheyne-Stokes respiration
- Current unstable angina
- Stroke
- Schizophrenia
- Untreated hypothyroidism
- Seizure disorder
- Preexisting renal failure and liver disorders
- Failure to give informed consent.
- Patients with significant pulmonary diseases by history and abnormal pulmonary function testing, including moderate obstructive/restrictive lung/chest wall disorders with resting oxygen saturation of <96% or on supplemental oxygen
- Patients on certain medications including:
- study drugs
- sympathomimetics/parasympathomimetics or their respective blockers
- narcotics
- antidepressants
- anti-psychotic agents
- other central nervous system (CNS) altering medications
- current alcohol, tobacco or recreational drug use
- Patients with Body mass index (BMI)>34 kilograms per square meter (kg/m2) will be excluded to avoid the effects of morbid obesity on pulmonary mechanics and ventilatory control
- Elderly with unstable gait or mobility issues that may preclude safe participation
- Individuals with allergy to finasteride or acetazolamide will be excluded from the specific protocol
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201-1916
Lynn M Huber, (313) 576-3106, lynn.huber@va.gov
Susmita Chowdhuri, MD MS
About this study
Official title: Pathophysiology-Guided Therapy for Sleep Apnea in the Elderly
Sleep-disordered breathing (SDB or sleep apnea) is very common among elderly Veterans and leads to increased morbidity and mortality in this population. The proposal aims to identity whether oxygen, finasteride and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in the elderly via different mechanisms. This proposal will enhance the investigators' understanding of the pathways that contribute to the development of sleep apnea in the elderly. The investigators expect that the results obtained from this study will positively impact the health of Veterans by identifying new treatment modalities for sleep apnea. A cumulative effect of the investigators' research will fulfill the long-term goal of improving the quality of life of elderly Veterans suffering from sleep apnea and its potential life-threatening complications.
Read the detailed description
Sleep apnea-hypopnea syndrome (SAHS) has a high prevalence and is associated with adverse cardiovascular consequences in elderly Veterans. Positive airway pressure therapy is deemed cumbersome and often associated with non-adherence to therapy. This proposal will investigate whether alternative therapies can be developed by modulating specific physiologic mechanisms of ventilatory control. Specifically, the investigators will study whether interventions with sustained hyperoxia (Aim 1), finasteride (Aim 2) and acetazolamide (Aim 3) will reduce breathing instability during sleep by reducing chemoresponsiveness and/or increasing cerebrovascular reactivity (CVR) in order to alleviate sleep disordered breathing in the elderly with sleep apnea. The proposed aims will also allow us to delineate key mechanisms of breathing instability in the elderly. The investigators envision that the results obtained from this project will ultimately allow us to develop novel alternative therapies for sleep apnea in the elderly. The investigators will also compare CVR in young vs older adults
- Conditions
- Sleep Apnea, Elderly Adults
- Being tested
- Hyperoxia/oxygen, Acetazolamide, Finasteride
- Keywords
- sleep apnea, chemoresponsiveness, cerebrovascular response, hyperoxia, acetazolamide, finasteride, apneic threshold, carbon-dioxide reserve
- Medical subject headings
- Sleep Apnea Syndromes, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperoxia/oxygenOther
The ventilatory effects of brief hyperoxia will be assessed by analyzing control breaths on room air immediately preceding the hyperoxic exposure, and comparing with the primary end-point, nadir minute ventilation breath, immediately following the brief hyperoxic exposure
AcetazolamideDrug
Participants with sleep apnea will ingest capsules containing either placebo or acetazolamide 500 mg twice a day for 5 days. On the final 2 consecutive nights while still on ACZ, the investigators will perform i) physiology tests and ii) in-lab follow-up PSG.
FinasterideDrug
Elderly males with sleep apnea and adequate testosterone levels will ingest placebo vs finasteride, at 5 mg a day for 1 month (mo). After 1 mo, while still on the drug, on the final 2 consecutive nights, the investigators will perform i) physiology tests and ii) in-lab follow-up PSG. Blood tests will be performed to check sex hormone levels. A washout period of 1 month prior to cross-over to the alternate arm (placebo).
| Study group | Role | What they receive |
|---|---|---|
| Hyperoxia | Experimental | 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. Receives: Other: Hyperoxia/oxygen |
| Acetazolamide (ACZ) | Experimental | 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. Receives: Drug: Acetazolamide |
| Finasteride | Experimental | Determine the effect of oral finasteride therapy vs placebo for 1 month on SDB and the AT and chemosensitivity during NREM sleep. Receives: Drug: Finasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apneic threshold- a measure of breathing instability
Measures of breathing instability including: Apneic threshold: this is the end-tidal Co2 at which a central apnea closes to a hypopnea is produced.
Measured: 2 days to 30 days
Cerebrovascular responsiveness to carbon-dioxide
Cerebrovascular response to different levels of CO2: this is a measure of the response of the cerebral blood flow to changes in carbon dioxide levels and is used as a measure of ventilatory control of breathing
Measured: 7 days
Ventilatory responsiveness
Hypocapnic ventilatory response; this is calculated as the change in minute ventilation for corresponding changes in PETCO2 (partial pressure of end-tidal carbon dioxide).
Measured: 2 days to 30 days
Carbon -dioxide reserve
This is a derived measure. This is calculated as the difference between the apneic threshold PETCO2 (given above) and the control PETCO2 (partial pressure of end-tidal carbon dioxide).
Measured: 2 days to 30 days
Secondary outcomes (1)
Apnea hypopnea index
Apnea hypopnea index- is a measure of severity of sleep apnea - this is calculated as the total number of apneas and hypopneas recorded during a sleep study divided by the total sleep time during the sleep study.
Measured: 2 days to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start3 Jul 2015
- Primary completion30 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susmita Chowdhuri, MD MS, Principal investigator, John D. Dingell VA Medical Center, Detroit, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703220
- Sponsor's protocol ID
- PULM-008-14F
- Status last verified
- Aug 2026
- First submitted
- 29 Jan 2016
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rastogi R, Badr MS, Ahmed A, Chowdhuri S. Amelioration of sleep-disordered breathing with supplemental oxygen in older adults. J Appl Physiol (1985). 2020 Dec 1;129(6):1441-1450. doi: 10.1152/japplphysiol.00253.2020. Epub 2020 Sep 24.
PubMed 32969781Rastogi R, Morgan BJ, Badr MS, Chowdhuri S. Hypercapnia-induced vasodilation in the cerebral circulation is reduced in older adults with sleep-disordered breathing. J Appl Physiol (1985). 2022 Jan 1;132(1):14-23. doi: 10.1152/japplphysiol.00347.2021. Epub 2021 Oct 28.
PubMed 34709067
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology-Guided Therapy for Sleep Apnea in the Elderly
- ClinicalTrials.gov ID
- NCT02703220
- Acronym / sponsor ID
- PULM-008-14F
- Conditions
- Sleep Apnea, Elderly Adults
- Keywords
- sleep apnea, chemoresponsiveness, cerebrovascular response, hyperoxia, acetazolamide, finasteride, apneic threshold, carbon-dioxide reserve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Jul 2015 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep-disordered breathing (SDB or sleep apnea) is very common among elderly Veterans and leads to increased morbidity and mortality in this population. The proposal aims to identity whether oxygen, finasteride and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in the elderly via different mechanisms. This proposal will enhance the investigators' understanding of the pathways that contribute to the development of sleep apnea in the elderly. The investigators expect that the results obtained from this study will positively impact the health of Veterans by identifying new treatment modalities for sleep apnea. A cumulative effect of the investigators' research will fulfill the long-term goal of improving the quality of life of elderly Veterans suffering from sleep apnea and its potential life-threatening complications.
Detailed description
Sleep apnea-hypopnea syndrome (SAHS) has a high prevalence and is associated with adverse cardiovascular consequences in elderly Veterans. Positive airway pressure therapy is deemed cumbersome and often associated with non-adherence to therapy. This proposal will investigate whether alternative therapies can be developed by modulating specific physiologic mechanisms of ventilatory control. Specifically, the investigators will study whether interventions with sustained hyperoxia (Aim 1), finasteride (Aim 2) and acetazolamide (Aim 3) will reduce breathing instability during sleep by reducing chemoresponsiveness and/or increasing cerebrovascular reactivity (CVR) in order to alleviate sleep disordered breathing in the elderly with sleep apnea. The proposed aims will also allow us to delineate key mechanisms of breathing instability in the elderly. The investigators envision that the results obtained from this project will ultimately allow us to develop novel alternative therapies for sleep apnea in the elderly. The investigators will also compare CVR in young vs older adults
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyperoxia | Experimental | Other: Hyperoxia/oxygenDetermine 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. |
| Acetazolamide (ACZ) | Experimental | Drug: AcetazolamideDetermine 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. |
| Finasteride | Experimental | Drug: FinasterideDetermine the effect of oral finasteride therapy vs placebo for 1 month on SDB and the AT and chemosensitivity during NREM sleep. |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with mild to moderate sleep apnea with Apnea-Hypopnea Index (AHI)>/=5 to 20/hour with central, obstructive, mixed apneas and hypopneas
- For the finasteride protocol elderly men with above criteria will be enrolled
Key exclusion criteria (27 listed)
- Patients with severe sleep apnea (Apnea-Hypopnea Index (AHI)>20/hour)
- Patients with history of prostate cancer
- Males with hypogonadism
- History of cardiac disease, including myocardial infarction
- Bypass surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperoxia/oxygenThe ventilatory effects of brief hyperoxia will be assessed by analyzing control breaths on room air immediately preceding the hyperoxic exposure, and comparing with the primary end-point, nadir minute ventilation breath, immediately following the brief hyperoxic exposure | Other | Hyperoxia |
| AcetazolamideParticipants with sleep apnea will ingest capsules containing either placebo or acetazolamide 500 mg twice a day for 5 days. On the final 2 consecutive nights while still on ACZ, the investigators will perform i) physiology tests and ii) in-lab follow-up PSG. | Drug | Acetazolamide (ACZ) |
| FinasterideElderly males with sleep apnea and adequate testosterone levels will ingest placebo vs finasteride, at 5 mg a day for 1 month (mo). After 1 mo, while still on the drug, on the final 2 consecutive nights, the investigators will perform i) physiology tests and ii) in-lab follow-up PSG. Blood tests will be performed to check sex hormone levels. A washout period of 1 month prior to cross-over to the alternate arm (placebo). | Drug | Finasteride |
Primary outcome
Apneic threshold- a measure of breathing instability
Time frame: 2 days to 30 days
Measures of breathing instability including: Apneic threshold: this is the end-tidal Co2 at which a central apnea closes to a hypopnea is produced.
Cerebrovascular responsiveness to carbon-dioxide
Time frame: 7 days
Cerebrovascular response to different levels of CO2: this is a measure of the response of the cerebral blood flow to changes in carbon dioxide levels and is used as a measure of ventilatory control of breathing
Ventilatory responsiveness
Time frame: 2 days to 30 days
Hypocapnic ventilatory response; this is calculated as the change in minute ventilation for corresponding changes in PETCO2 (partial pressure of end-tidal carbon dioxide).
Carbon -dioxide reserve
Time frame: 2 days to 30 days
This is a derived measure. This is calculated as the difference between the apneic threshold PETCO2 (given above) and the control PETCO2 (partial pressure of end-tidal carbon dioxide).
1 secondary outcome
Apnea hypopnea index
Time frame: 2 days to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Results publication: PubMed 32969781Rastogi R, Badr MS, Ahmed A, Chowdhuri S. Amelioration of sleep-disordered breathing with supplemental oxygen in older adults. J Appl Physiol (1985). 2020 Dec 1;129(6):1441-1450. doi: 10.1152/japplphysiol.00253.2020. Epub 2020 Sep 24.
- Results publication: PubMed 34709067Rastogi R, Morgan BJ, Badr MS, Chowdhuri S. Hypercapnia-induced vasodilation in the cerebral circulation is reduced in older adults with sleep-disordered breathing. J Appl Physiol (1985). 2022 Jan 1;132(1):14-23. doi: 10.1152/japplphysiol.00347.2021. Epub 2021 Oct 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susmita Chowdhuri, MD MS principal investigator
John D. Dingell VA Medical Center, Detroit, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperoxia/oxygen, Acetazolamide and Finasteride in people with Sleep Apnea and Elderly Adults, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruchi Rastogi, MS ((313) 576-4464, ruchi.rastogi@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apneic threshold- a measure of breathing instability (time frame: 2 days to 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02703220, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.