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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
Sponsor:
Information provided by (Responsible Party):
Robert L. Owens, University of California, San Diego

Brief 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: Venlafaxine Drug: Placebo Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Venlafaxine
50mg of Venlafaxine before sleep
Drug: Venlafaxine
Venlafaxine 50mg before sleep

Placebo Comparator: Placebo
One piece of placebo before sleep
Drug: Placebo
One piece of placebo before sleep




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, California
University of California, San Diego
San Diego, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego

Publications:
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Responsible Party: Robert L. Owens, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02714400     History of Changes
Other Study ID Numbers: UCSD141272ARM5-1
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Keywords provided by Robert L. Owens, University of California, San Diego:
Obstructive Sleep Apnea
Arousal threshold
Venlafaxine
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs