The Impact of Venlafaxine on Apnea Hypopnea Index in Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT02714400|
Recruitment Status : Active, not recruiting
First Posted : March 21, 2016
Last Update Posted : March 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Drug: Venlafaxine Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||The Impact of Venlafaxine on Apnea Hypopnea Index in Patients With Obstructive Sleep Apnea|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Venlafaxine
50mg of Venlafaxine before sleep
Venlafaxine 50mg before sleep
Placebo Comparator: Placebo
One piece of placebo before sleep
One piece of placebo before sleep
- The Apnea hypopnea index [ Time Frame: 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 [ Time Frame: 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.
- Loop gain [ Time Frame: Baseline and 7-day follow up ]Loop gain is used to describe the stability of ventilatory control. The change from baseline in loop gain after a single dose of Venlafaxine will be estimated.
- Arousal threshold [ Time Frame: Baseline and 7-day follow up ]Change from baseline in respiratory arousal threshold after single dose of Venlafaxine will be estimated.
- Sleep efficiency [ Time Frame: Baseline and 7-day follow up ]Change from baseline in sleep efficiency after single dose of Venlafaxine will be estimated using overnight polysomnography.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714400
|United States, California|
|University of California, San Diego|
|San Diego, California, United States, 92093|