Sleep Disordered Breathing With Opioid Use
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-89
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Veterans, age 18-89 years
Veterans with prescription opioids
Disqualifiers
Patients with BMI>40kg/m2 will be excluded to avoid the effects of morbid obesity on pulmonary mechanics and ventilatory control
Patients with history of unresolved/untreated cardiac disease, including recent myocardial infarction, recent bypass surgery, untreated atrial and ventricular tachy-bradycardias
Congestive heart failure with Cheyne-Stokes respiration (CSR)
Current unstable angina
Trial design
Design model
Crossover
Treatments tested in this trial
Hyperoxia
Other interventionThe 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
DrugParticipants 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: HyperoxiaExperimental treatment 1 intervention
Group B: Acetazolamide (ACZ)Experimental 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 days2
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 days3
Ventilatory responsiveness
Hypocapnic ventilatory response; this is calculated as the change in minute ventilation for corresponding changes in PETCO2.
Time frame
2 days to 30 days4
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.
Time frame
2 days to 30 daysSecondary 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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
John D. Dingell VA Medical Center
Collaborator
Source ClinicalTrials.gov