Sleep Disordered Breathing With Opioid Use

Part of paid clinical trials in Detroit, Michigan.

Sponsor
VA Office of Research and Development
Study ID
NCT05589753
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • Hyperoxia — OTHER
    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 6 days. On the final 4 consecutive nights while still on ACZ, the investigators will perform i) physiology tests and ii) in-lab follow-up PSG.

Study Details

There is an increased risk for sleep disordered breathing (SDB), sleep-related hypoventilation and irregular breathing in individuals on chronic prescription opioid medications. Almost 30% of a veteran sleep clinic population had opioid-associated central sleep apnea (CSA). The proposal aims to identity whether oxygen and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in chronic opioid use via different mechanisms. We will study additional clinical parameters like quality of life, sleep and pain in patients with and without opioid use. This proposal will enhance the investigators' understanding of the pathways that contribute to the development of sleep apnea with opioid use. 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.

Key Dates

Start date
May 2, 2019
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Hyperoxia
    Determine the effect of sustained hyperoxia overnight vs room air overnight on ventilatory control during sleep, including the apneic threshold, carbon-dioxide reserve and chemosensitivity measured via pressure support ventilation (PSV) during non-rapid eye movement sleep (NREM) sleep.
  • Experimental: Acetazolamide (ACZ)
    Determine the effect of acetazolamide on cerebrovascular responsiveness to CO2 during wake and sleep. Participants will receive oral ACZ therapy for 6 days, While on the medication following studies will be performed - experimental night study, experimental day study, polysomnography night study (PSG).

Primary Outcome Measure

Apneic threshold- a measure of breathing instability [ Time Frame: 2 days to 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
John D. Dingell VA Medical Center, Detroit, MIDetroitMichigan48201-1916
Ruchi Rastogi, MS
[email protected]
313-576-4464
Susmita Chowdhuri, MD MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Detroit, MI

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
John D. Dingell VA Medical Center, Detroit, MI· Detroit, MI

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