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Trazodone Dose Tolerance and APAP Adherence (TrazoDose)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02945644
Recruitment Status : Suspended (COVID19 pandemic)
First Posted : October 26, 2016
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Kingman Strohl, Louis Stokes VA Medical Center

Brief Summary:
Trazodone may help obstructive sleep apnea patients to stick to their therapy, but optimal dosing is unknown. This study looks at what dose of trazodone has the best balance of potential benefits to side-effects in people with obstructive sleep apnea who are either starting on positive airway pressure therapy or not adherent to it. Participants will be randomly assigned to one of three groups: trazodone 50 mg, trazodone 100 mg, or placebo for 14 days. The investigators will monitor side-effects and adherence to positive airway pressure therapy.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Drug: Trazodone Drug: Placebo Phase 1

Detailed Description:

Clinical Significance: Trazodone is an often-used medication in clinical sleep medicine. However, there is a dearth of information on side-effects with doses typically used for sleep. In addition, a significant proportion of the VA population have obstructive sleep apnea for which the primary treatment is positive airway therapy. However, many patients have difficulty adhering to this treatment long-term. Increased adherence to this modality has been shown to improve risk for cardiovascular and neurologic co-morbidity associated with obstructive sleep apnea. This project explores both the tolerability and safety of common doses of trazodone used in clinical sleep practice as well explores potential effects on positive airway pressure therapy adherence.

Objectives: This project seeks to determine the tolerability and multi-domain effect on sleep and mood of a 14 day course of trazodone at either 50 mg or 100 mg or placebo.

Research Plan: This is a three-group, randomized, double-blind, placebo-controlled trial with prospective data collection of VA outpatient sleep clinic patients with obstructive sleep apnea with who are non-adherent or newly started on auto-titrating positive airway pressure therapy. Evaluation focuses on medication tolerability as measured by number of days before study drug discontinuation by the participant, the Treatment Satisfaction Questionnaire for Medication, the side-effect profile at the two doses (50mg and 100mg) compared to placebo as well as longitudinal collection of adherence data and standardized questionnaires on sleepiness, insomnia, depression, anxiety, and self-efficacy. The investigators also plan to longitudinally monitor coefficient of variation of breath-to-breath tidal volume, a measure of respiratory mechanics which may be affected by trazodone use. Study participants will have 2 visits at baseline and 2 weeks after randomization.

Methodology: This study will be conduced in the Louis Stokes Cleveland Medical Center - Wade Park Sleep Clinic, a tertiary institutional referral facility. Participants must be adults with obstructive sleep apnea prescribed auto-titrating positive airway therapy who are either newly initiated or do not fulfill standard criteria for adherence and do not have allergy to trazodone; current use of trazodone, monoamine oxidase inhibitors, or sedative hypnotics; alcohol or drug abuse; severe psychiatric disease; epilepsy; significant cardiac disease; liver disease; pregnancy; hypotension; or predisposition to priapism. Study staff will interview the potential participant and do a review of the medical record for exclusion criteria before consent is obtained. The investigators expect to recruit 45 participants into the study with a 20% attrition rate before completion. Hypothesis about the tolerability of trazodone and effect on positive airway therapy adherence was prespecified.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Trazodone Dose Tolerance and APAP Adherence
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Placebo Comparator: Placebo
pill filled with inert material
Drug: Placebo
take at bedtime for 14 days

Active Comparator: Trazodone 50mg Drug: Trazodone
take at bedtime for 14 days
Other Names:
  • oleptro
  • Desyrel

Active Comparator: Trazodone 100mg Drug: Trazodone
take at bedtime for 14 days
Other Names:
  • oleptro
  • Desyrel




Primary Outcome Measures :
  1. Discontinuation rate by participant [ Time Frame: 14-16 days post-randomization ]
    Did the participant discontinue trazodone at a higher rate than placebo?


Secondary Outcome Measures :
  1. 3 month APAP adherence [ Time Frame: 3 months post-randomization assessing 30 days before this 3 month period ]
    APAP use in last 30 days (of the 3 month period) as measured by (1) average hours/day and (2) percent days with 4 or more hours use

  2. Respiratory patterning [ Time Frame: 14-16 days post-randomization ]
    Variation of breath to breath tidal volume obtained from plethysmography (a stretchy band around the chest x 20 minutes while wearing APAP)

  3. Medication Satisfaction [ Time Frame: 14-16 days post-randomization ]
    Treatment Satisfaction Questionnaire for Medications version II overall and subscale scores

  4. side-effect profile [ Time Frame: 14-16 days post-randomization ]
    participant-reported side effects of study drug

  5. sleepiness [ Time Frame: 14-16 days post-randomization ]
    Epworth Sleepiness Scale

  6. insomnia [ Time Frame: 14-16 days post-randomization ]
    Insomnia Severity Index

  7. general self-efficacy [ Time Frame: 14-16 days post-randomization ]
    General Self-Efficacy Scale

  8. depression [ Time Frame: 14-16 days post-randomization ]
    Clinically Useful Depression Outcome Scale (CUDOS)

  9. anxiety [ Time Frame: 14-16 days post-randomization ]
    Clinically Useful Anxiety Outcome Scale (CUXOS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Louis Stokes Cleveland VA Sleep Medicine clinic patient
  • AHI greater than or equal to 5
  • obstructive sleep apnea
  • new initiation or nonadherence to APAP

Exclusion Criteria:

  • schizophrenia
  • bipolar disorder
  • current use of trazodone or sedative hypnotics
  • allergy to trazodone
  • current use of tricyclic antidepressants or monoamine oxidase inhibitors
  • current alcohol or drug abuse
  • heart failure
  • heart attack in past 3 months
  • congenital long QT, ventricular arrhythmia (including Torsades de Pointes), bradycardia, or digoxin therapy
  • use of amiodarone, sotalol, dofetilide, or dronedarone
  • epilepsy
  • liver disease
  • pregnancy (or planning pregnancy)
  • right of priapism: history of priapism, sickle cell disease, Farby disease

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): NCT02945644


Locations
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United States, Ohio
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Louis Stokes VA Medical Center
Investigators
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Principal Investigator: Kingman P Strohl, MD Louis Stokes Cleveland VA Medical Center
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Responsible Party: Kingman Strohl, Professor, Louis Stokes VA Medical Center
ClinicalTrials.gov Identifier: NCT02945644    
Other Study ID Numbers: 16025-H17
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kingman Strohl, Louis Stokes VA Medical Center:
obstructive sleep apnea
trazodone
positive airway pressure
adherence
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Trazodone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents