Sleep Apnea in Elderly (NCT02703220) | Clinical Trial Compass
RecruitingPhase 4
Sleep Apnea in Elderly
United States100 participantsStarted 2015-07-03
Plain-language 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.
Who can participate
Age range
60 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* For the finasteride protocol elderly men with above criteria will be enrolled.
Exclusion Criteria:
* Patients with severe sleep apnea (AHI\>20/hr)
* 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 BMI\>34kg/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 precl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Apneic threshold- a measure of breathing instability