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
Qualifiers
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
Treatments tested in this trial
- Morphine p.o.
- Placebo
Treatment groups
26 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov