NCT06854211尚未招募1 期
Mechanisms of Opioid-induced Respiratory Depression (OIRD) During Sleep
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The change in ventilation (L) per minute during stable sleep with morphine versus placebo.
研究概览
简要总结
The investigators are studying the impact that opioids have on breathing during sleep in healthy participants and those diagnosed with obstructive sleep apnea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •current use of central nervous system depressants.
- •individuals with gastrointestinal obstruction. Constipation is not an exclusion criterion because morphine is only administered for one night.
- •recent head injury, brain tumors, or other conditions leading to increased intracranial pressure.
- •unstable heart disease, particularly those with risk factors for or a history of heart rhythm disorders.
- •epilepsy or a history of seizures, as morphine can lower the seizure threshold.
- •severe psychiatric conditions, particularly those with a history of psychosis, as opioids can exacerbate these conditions.
- •medications that interact with morphine, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), Monoamine oxidase inhibitors (MAOIs), and the atypical antidepressants buproprion and trazodone.
- •untreated or unstable endocrine disorders like adrenal insufficiency or thyroid dysfunction.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Morphine
Active Comparator
干预措施: Morphine p.o. (Drug)
结局指标
主要结局
The change in ventilation (L) per minute during stable sleep with morphine versus placebo.
时间窗: From enrollment to the end of treatment at 6 weeks.
The primary outcome, determining the change in ventilation in liters per minute, will be analyzed on both subpopulations (controls and people with obstructive sleep apnea) using generalized linear mixed models with treatment, period and sequence as fixed effects and a random effect of participant nested within sequence.
次要结局
未报告次要终点
研究者
Danny J. Eckert
Principal Investigator
Brigham and Women's Hospital
研究点 (1)
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