Control of Ventilation During Wakefulness in Opioid vs. Non-opioid Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Respiratory pattern changes during standardized cognitive load tasks
研究概览
简要总结
The goal of this observational study is to find out if using your brain for a mental task changes how you breathe. Researchers want to compare three groups of adults: people who take opioid pain medicine every day, people with sleep apnea, and healthy people with neither condition. The main questions this study aims to answer are:
- Does breathing change differently during mental tasks in people who take opioids, people with sleep apnea, and healthy controls?
- Is the connection between brain activity and breathing disrupted more in people who use chronic opioids or have OSA, compared with healthy controls, during periods of mental effort?
Researchers will compare the three groups to see if opioid use or sleep apnea makes breathing less steady, or weakens the link between the brain and breathing, when a person is concentrating on a task.
Participants will visit the UC San Diego Sleep Laboratory one time. During the visit, they will:
- Answer questions about sleep, opioid use, and sleep apnea risk.
- Have sensors placed on their skin and scalp to measure brain waves, breathing, and oxygen levels. This is the same kind of equipment used in a regular sleep study, and it does not hurt.
- Sit quietly and rest while their breathing and brain waves are recorded.
- Do a series of short mental tasks on a computer, tablet, or paper, testing things like memory, attention, and thinking speed, while their breathing and brain waves continue to be recorded.
No medicine or treatment will be given during the study, and no blood or other samples will be collected. This study only involves watching and measuring, not testing any treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants
- •Able to provide informed consent
- •Able to communicate in English, see/hear task stimuli (with usual corrective devices), follow multistep instructions, and complete a brief cognitive-task practice example
- •Opioid group
- •Daily prescribed opioid use, under medical supervision, for chronic non-cancer pain, for ≥3 months
- •Prescribed dose ≥20 MME/day (no upper limit)
- •Stable dose for ≥2 weeks
- •- Diagnosed OSA with AHI ≥15 events/hour (documented on a prior clinical sleep study)
- •Healthy control group
- •No history of chronic prescribed opioid use
- •No known history/diagnosis of OSA
- •If a prior sleep study exists, AHI must be <10 events/hour within the past 3 years
排除标准
- •Prisoners
- •Pregnancy
- •BMI <20 or >35
- •Unable/unwilling to give informed consent or comply with study procedures
- •Significant comorbidities of other organ systems (e.g., chronic kidney disease, CHF/active cardiac symptoms, cirrhosis, severe lung disease)
- •Diseases affecting respiratory muscles or breathing control (neuromuscular, neurodegenerative, congenital)
- •Psychiatric disease other than controlled mood disorders
研究组 & 干预措施
Opioid Use
Obstructive Sleep Apnea
Healthy Control Group
结局指标
主要结局
Respiratory pattern changes during standardized cognitive load tasks
时间窗: 2 hours
Respiratory variability/irregularity
时间窗: 2 hours
Measured from breathing signals (nasal pressure/airflow, thoracoabdominal effort belts, end-tidal CO2) during cognitive tasks vs. baseline
次要结局
- EEG-respiratory coupling(2 hours)
研究者
Jeremy Orr, M.D.
Associate Professor of Medicine
University of California, San Diego
