Impacts of Opioids on Respiratory Drive During Sleep
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrigham and Women's Hospital
About this trial
The investigators are studying the impact that opioids have on breathing during sleep in healthy participants and those diagnosed with obstructive sleep apnea.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy controls: Apnea Hypopnea Index (AHI) < 5 events/hr on in-laboratory PSG within 3 months of enrollment
OSA group: AHI > 10 events/hr on in-laboratory PSG within 3 months of enrollment; treated or untreated.
Disqualifiers
Sleep disordered breathing or respiratory disorders (other than OSA in the OSA group), such as central sleep apnea (>50% of respiratory events scored as central), chronic hypoventilation/hypoxemia (awake SaO2 < 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
Other sleep disorders: periodic limb movements (periodic limb movement index > 20/hr), narcolepsy, or parasomnias.
Any unstable major medical condition.
Medications expected to stimulate or depress respiration (including other opioids taken at home, barbiturates, benzodiazepines, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
Trial design
Design model
Parallel
Treatments tested in this trial
Morphine p.o.
DrugMorphine 50mg PO will be given on sleep study night.
Placebo
DrugPlacebo will be given on the sleep study night.
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: MorphineActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The change in ventilation (L) per minute during stable sleep with morphine versus placebo.
The primary outcome, determining the change in ventilation in liters per minute, will be analyzed on both subpopulations (controls and people with obstructive sleep apnea) using generalized linear mixed models with treatment, period and sequence as fixed effects and a random effect of participant nested within sequence.
Time frame
From enrollment to the end of treatment at 6 weeks.Sponsors and contacts
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Source ClinicalTrials.gov
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