University of California, San Diego
This study will evaluate whether supplemental oxygen given during sleep improves breathing stability and sleep-disordered breathing in adults who use prescription opioids long term. Participants will receive both supplemental oxygen and sham air during separate overnight sleep studies in a randomized order. The two study conditions will be separated by a washout period of approximately one week. Researchers will compare breathing during sleep with supplemental oxygen versus sham air and will also evaluate measures of oxygen levels, carbon dioxide levels, sleep quality, alertness, and other aspects of breathing and sleep. For participants who previously took part in the GENESIS study, qualifying assessments from that study may be used to meet certain baseline requirements when appropriate, which may reduce the need to repeat some testing.
This is a Phase II, single-center, randomized, double-blind, sham-controlled crossover study evaluating the effects of nocturnal supplemental oxygen on ventilatory stability and sleep-disordered breathing in adults receiving chronic opioid therapy. Eligible participants will be randomized to one of two treatment sequences: supplemental oxygen followed by sham air, or sham air followed by supplemental oxygen. Each intervention will be administered during a separate in-laboratory overnight polysomnography (PSG) visit, with an approximately 1-week washout period between intervention nights. Each…
Inclusion Criteria: * Age 18 to 75 years. * Chronic opioid use for ≥3 months with a daily opioid dose equivalent to at least 20 mg of oral morphine (morphine equivalent daily dose \[MEqD\]). Examples include approximately 13 mg oxycodone, 20 mg hydrocodone, 100 mg tramadol, or equivalent doses of other opioids. * Ability and willingness to comply with study procedures, including overnight laboratory polysomnography and administration of oxygen or sham air in the laboratory. * Ability to provide written informed consent. * For participants able to become pregnant: agreement to use an effective…
Sham air will be delivered during sleep through a nasal cannula using a standard wall air flow controller during an in-laboratory overnight polysomnography (PSG). Sham air will be delivered at a fixed flow rate of 4 L/min and may be reduced to 3 L/min for participant comfort.
Supplemental oxygen will be delivered during sleep through a nasal cannula using a standard wall oxygen flow controller during an in-laboratory overnight polysomnography (PSG). Supplemental oxygen will be delivered at a fixed flow rate of 4 L/min and may be reduced to 3 L/min for participant comfort.
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