Completed

Venlafaxine's Impact on Apnea Hypopnea Index in Obstructive Sleep Apnea Patients

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What is being tested

Venlafaxine

+ Placebo

Drug
Who is being recruted

Apnea+6

+ Nervous System Diseases

+ Respiration Disorders

From 18 to 70 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: March 2016
See protocol details

Summary

Principal SponsorUniversity of California, San Diego
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2016

Actual date on which the first participant was enrolled.

This study is about exploring the effects of Venlafaxine, a medication typically used to treat depression and anxiety, on Obstructive Sleep Apnea (OSA). The study's main goal is to see if Venlafaxine can improve the Apnea Hypopnea Index, a measure of sleep apnea severity. The study focuses on adults with OSA, as they may benefit from improved arousal threshold and upper airway muscle tone, which are potentially influenced by increased serotonin levels from Venlafaxine. The potential outcomes of this study could lead to new treatment options for individuals with OSA, addressing an important unmet need in sleep medicine. In this study, participants will undergo an overnight sleep study called polysomnography and receive either Venlafaxine or a placebo, in a random order. The Venlafaxine dose will be administered 2 hours before sleep. After about 7 days, participants will receive the alternate treatment (placebo or Venlafaxine). The study will evaluate changes in the Apnea Hypopnea Index and the lowest oxygen level during sleep after a single dose of Venlafaxine, comparing these results to the placebo group. The study aims to determine whether Venlafaxine can lead to improvements in these measures, potentially offering a new treatment approach for OSA.

Official TitleThe Impact of Venlafaxine on Apnea Hypopnea Index in Patients With Obstructive Sleep Apnea
NCT02714400
Principal SponsorUniversity of California, San Diego
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Apnea SyndromesSleep Wake DisordersSleep Apnea, ObstructiveSleep Disorders, IntrinsicDyssomnias

Criteria

3 inclusion criteria required to participate
Ages 18-70 years
sleep study (with apnea hypopnea index>5)
Diagnosis of obstructive sleep apnea
13 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
50mg of Venlafaxine before sleep

Group II

Placebo
One piece of placebo before sleep

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of California, San Diego

San Diego, United StatesOpen University of California, San Diego in Google Maps
CompletedOne Study Center