Impacts of Opioids on Respiratory Drive During Sleep (NCT06854211) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Impacts of Opioids on Respiratory Drive During Sleep
United States26 participantsStarted 2026-07-01
Plain-language summary
The investigators are studying the impact that opioids have on breathing during sleep in healthy participants and those diagnosed with obstructive sleep apnea.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
* History of allergy to lidocaine or oxymetazoline.
* Contraindications for morphine, including:
* allergy to morphine or opioids
* chronic obstructive pulmonary disease, asthma, or other significant respiratory disorders
* kidney or liver dysfunction, as this can affect the metabolism and excretion of morphine, leading to increased risk of toxicity.
* women who are pregnant or breastfeeding will be excluded due to potential risks to the fetus or infant.
* history of substance abuse, particularly opioid abuse, will be excluded to prevent potential misuse or relapse.
* curr…
What they're measuring
1
The change in ventilation (L) per minute during stable sleep with morphine versus placebo.
Timeframe: From enrollment to the end of treatment at 6 weeks.