| NCT ID | NCT02703220 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | VA Office of Research and Development |
| Condition | Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2015-07-03 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2015-07-03 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
Susmita Chowdhuri, MD MS
PRINCIPAL INVESTIGATOR
John D. Dingell VA Medical Center, Detroit, MI
Frequently Asked Questions
Who can join the NCT02703220 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 89 Years, studying Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02703220 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT02703220 currently recruiting?
Yes, NCT02703220 is actively recruiting participants. Contact the research team at ruchi.rastogi@va.gov for enrollment information.
Where is the NCT02703220 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT02703220 clinical trial?
NCT02703220 is sponsored by VA Office of Research and Development. The principal investigator is Susmita Chowdhuri, MD MS at John D. Dingell VA Medical Center, Detroit, MI. The trial plans to enroll 100 participants.