Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment

Part of paid clinical trials in Detroit, Michigan.

Sponsor
VA Office of Research and Development
Study ID
NCT07210606
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Able Bodied
  • Sleep Disordered Breathing

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Trazodone + PAP therapy — DRUG
    The central apnea index and the apneic threshold will be compared under two conditions: trazodone or placebo. In addition, participants will get PAP therapy during both the conditions.
  • Oxygen + PAP therapy — DRUG
    The central apnea index and the apneic threshold will be compared under two conditions: oxygen or room air. In addition, participants will get PAP therapy during both the conditions.

Study Details

Central sleep apnea (CSA) is common in patients with heart failure and those using opioid analgesics. Unfortunately, effective treatment of central apnea remains elusive, pressure therapy given the modest efficiency of positive airway pressure therapy. The focus of this proposal is to identify mechanistic pathways to guide future therapeutic interventions for central sleep apnea based on the strong premise that multi-modality therapy will normalize respiration and hence mitigate adverse long-term consequences of CSA. The investigators' proposed studies will test combination therapies, including positive airway pressure (PAP) plus a pharmacological agent who have heart failure or are using opioid analgesics. The investigators anticipate that findings will inform future clinical trials to improve care and quality of life among Veterans suffering from central sleep apnea, which remains difficult to treat using existing approaches.

Key Dates

Start date
Oct 1, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Trazodone
    To determine the effect of dampening respiratory arousals. The investigators hypothesize that PAP therapy with trazodone at 100 mg will be superior to CPAP alone in widening the CO2 reserve during sleep, decreasing respiratory arousals, and increasing the arousal threshold.
  • Active Comparator: Oxygen
    To determine the effect of dampening peripheral chemoreceptor sensitivity. The investigators hypothesize that supplemental oxygen will be superior to CPAP alone in widening the CO2 reserve during sleep. The secondary analysis will use CAI as supplemental oxygen, which may obscure the detection of hypopneas based on desaturation.

Primary Outcome Measure

CO2 Reserve [ Time Frame: 120 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
John D. Dingell VA Medical Center, Detroit, MIDetroitMichigan48201-1916
Susmita Chowdhuri, MD MS
[email protected]
(313) 576-4451
Lynn M Huber
[email protected]
(313) 576-3106
M Safwan Badr, MD (PRINCIPAL_INVESTIGATOR)

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By research site
John D. Dingell VA Medical Center, Detroit, MI· Detroit, MI

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