Clinical trial

Pathophysiology-Guided Therapy for Sleep Apnea in the Elderly

Name

PULM-008-14F

Description

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.

Trial arms

Trial start

2015-07-03

Estimated PCD

2024-06-30

Trial end

2024-06-30

Status

Recruiting

Phase

Early phase I

Treatment

Hyperoxia/oxygen

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

Arms:

Hyperoxia

Acetazolamide

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.

Arms:

Acetazolamide (ACZ)

Finasteride

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).

Arms:

Finasteride

Size

100

Primary endpoint

Apneic threshold- a measure of breathing instability

2 days to 30 days

Cerebrovascular responsiveness to carbon-dioxide

7 days

Ventilatory responsiveness

2 days to 30 days

Carbon -dioxide reserve

2 days to 30 days

Eligibility criteria

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 preclude safe participation * Individuals with allergy to finasteride or acetazolamide will be excluded from the specific protocol * Pregnant women

Protocol

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Updated at

2023-08-18

1 organization

1 product

1 drug

2 indications

Organization

VA Office of Research and Development

Product

Indication

Indication

Drug