Health TrialsbyHealthPanel

Sleep Apnea in Elderly

ConditionsSleep ApneaElderly Adults
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60-89
SponsorVA Office of Research and Development

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Hyperoxia/oxygen

    Other intervention

    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

  • Acetazolamide

    Drug

    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.

  • Finasteride

    Drug

    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).

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: HyperoxiaExperimental treatment 1 intervention
Group B: Acetazolamide (ACZ)Experimental treatment 1 intervention
Group C: FinasterideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 days to 30 days
2

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

Time frame
7 days
3

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).

Time frame
2 days to 30 days
4

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).

Time frame
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.

Time frame
2 days to 30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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