The Impact of Venlafaxine on Apnea Hypopnea Index in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Venlafaxine; Placebo
Intervention description: Venlafaxine 50mg before sleep; One piece of placebo before sleep
Intervention MeSH terms: Venlafaxine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Obstructive Sleep Apnea; Arousal threshold; Venlafaxine

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-70 years

          -  sleep study (with apnea hypopnea index>5)

          -  Diagnosis of obstructive sleep apnea

        Exclusion Criteria:

          -  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