The Impact of Venlafaxine on Apnea Hypopnea Index in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The Apnea Hypopnea Index
研究概览
简要总结
The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low arousal threshold may wake up too early during a respiratory event, before upper airway muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the respiratory arousal threshold could potentially improve the quality of sleep and sleep disordered breathing. Agents that raise arousal threshold are therefore likely to benefit some patients with OSA. The overall goal of this project is to determine the importance of the arousal threshold in OSA, determine which patients might benefit from a raised arousal threshold, and test this hypothesis by using pharmacological manipulation of the arousal threshold to achieve this goal.
详细描述
This study is a randomized double-blinded crossover pilot study. The investigators will test whether Venlafaxine has important effects on the apnea hypopnea index. Venlafaxine is a serotonin-norepinephrine reuptake inhibitor (SNRI) for the treatment of depression and anxiety. Venlafaxine increases serum serotonin level, which may affect arousal threshold. Furthermore, higher serotonin level theoretically may improve muscle tone, including upper airway muscle. Therefore, the investigators hypothesize that venlafaxine may decrease arousal threshold and improve muscle tone, leading to improvement of OSA.
Eligible participants will undergo overnight polysomonography as described below and will receive either Venlafaxine(50 mg 2 hour prior to sleep) or placebo (in random order) followed roughly 7 days later with placebo or donepezil. This aim will allow us to test the impact of Venlafaxine on the apnea hypopnea index.
The change in apnea hypopnea index will be compared in the Venlafaxine groups with the placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-70 years
- •sleep study (with apnea hypopnea index>5)
- •Diagnosis of obstructive sleep apnea
排除标准
- •Any known cardiac (apart from treated hypertension), pulmonary (including uncontrolled asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease.
- •Susceptible to stomach ulcers.
- •co-administration of MAO inhibitors intended to treat psychiatric disorders (concurrently or within 14 days of discontinuing the MAO inhibitor); initiation of MAO inhibitor intended to treat psychiatric disorders within 7 days of discontinuing venlafaxine; initiation in patients receiving linezolid or intravenous methylene blue
- •Pregnant women.
- •History of hypersensitivity to Afrin, Lidocaine (all Aims) or venlafaxine
- •History of bleeding diathesis and/or gastrointestinal bleeding.
- •Glaucoma and Urinary Retention
- •Use of any medications that may affect sleep or breathing.
- •Use of any medications that have known interaction with venlafaxine and the interaction may significantly increase the risk of the subject or decrease the therapeutic effect of the medication.
- •A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
- •Substantial cigarette (>5/day), alcohol (>3oz/day) or use of illicit drugs.
- •More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
- •Desaturations to below 70% lasting greater than 10 seconds in duration per event
研究组 & 干预措施
Venlafaxine
50mg of Venlafaxine before sleep
干预措施: Venlafaxine (Drug)
Placebo
One piece of placebo before sleep
干预措施: Placebo (Drug)
结局指标
主要结局
The Apnea Hypopnea Index
时间窗: Baseline and 7-day follow up
The Apnea hypopnea index is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The change from baseline in apnea hypopnea index after a single dose of Venlafaxine will be evaluated using overnight polysomnography. An apnea hypopnea index less than five events per hour is considered within normal limits.
Nadir Oxygen Level During Sleep
时间窗: Baseline and 7-day follow up
Change from baseline in nadir oxygen level during sleep after a single dose of Venlafaxine will be evaluated using overnight polysomnography. A lower blood oxygen saturation during sleep is associated with a more severe obstructive sleep apnea.
次要结局
- Loop Gain(Baseline and 7-day follow up)
- Arousal Threshold(Baseline and 7-day follow up)
- Sleep Efficiency(Baseline and 7-day follow up)
研究者
Robert L. Owens
Assistant Professor
University of California, San Diego