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Venlafaxine for Obstructive Sleep Apnea
NCT02714400Phase 4
Key facts
- Status
- Completed
- Start
- Mar 2016
- Primary completion
- Jul 2016
- Countries
- 1
- Sponsor
- University of California, San Diego
- Modality
- Small Molecules
- Drugs
- venlafaxine
- Conditions
- obstructive sleep apnea (OSA)
01
Overview
Phase 4, randomised, double-blind trial in obstructive sleep apnea (OSA) comparing Venlafaxine with Placebo (2 arms). Primary endpoints: Apnea Hypopnea Index at 7 days and Nadir Oxygen Level During Sleep at 7 days. Started Mar 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Venlafaxine
50mg of Venlafaxine before sleep
Placebo
Placebo before sleep
03
Who it enrols
Adult patients aged 18-70 with a diagnosis of obstructive sleep apnea (AHI > 5) are eligible. Patients with significant cardiac, pulmonary, renal, neurologic, or hepatic disease, those susceptible to stomach ulcers, pregnant women, or those taking MAO inhibitors or other medications affecting sleep/breathing are excluded.
04
Endpoints
Primary
Apnea Hypopnea Index
Nadir Oxygen Level During Sleep
Secondary
Loop Gain
Arousal Threshold
Sleep Efficiency
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