Sleep-Disordered Breathing clinical trials at UCSD

The REDUCE study will evaluate whether referral to a comprehensive opioid management program improves breathing stability during sleep in adults with chronic opioid use and sleep-disordered breathing. This is a Phase II, single-center, randomized, controlled study. Participants will be randomly assigned to either usual care or referral to the UC San Diego Opioid Management Program. Participants referred to the program will receive individualized opioid and pain management from their treating clinician or designated opioid management provider. Treatment may include changes to opioid medications and other pain-management strategies when clinically appropriate. The research team will not prescribe opioids or direct opioid dose adjustments, and no opioid dose reductions are required by the study. Participants will be followed for approximately 26 weeks. Study assessments will include overnight sleep studies, questionnaires, blood collection, psychomotor vigilance testing, and regular safety monitoring. The primary objective is to determine whether comprehensive opioid management improves ventilatory stability compared with usual care.

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.