The Impact of Venlafaxine on Apnea Hypopnea Index in Obstructive Sleep Apnea

Completed · Phase 4 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT02714400

Run by

University of California, San Diego

People needed

20

Starts

2016-03-01

Expected to finish

2016-07-01

Last updated by the study team

2020-04-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 18-70 years
• sleep study (with apnea hypopnea index>5)
• Diagnosis of obstructive sleep apnea

You may not qualify if…

• 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

Where it is running

• University of California, San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.