Trazodone Dose Tolerance and APAP Adherence (TrazoDose)
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|ClinicalTrials.gov Identifier: NCT02945644|
Recruitment Status : Suspended (COVID19 pandemic)
First Posted : October 26, 2016
Last Update Posted : May 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive||Drug: Trazodone Drug: Placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Placebo Comparator: Placebo
pill filled with inert material
take at bedtime for 14 days
|Active Comparator: Trazodone 50mg||
take at bedtime for 14 days
|Active Comparator: Trazodone 100mg||
take at bedtime for 14 days
- Discontinuation rate by participant [ Time Frame: 14-16 days post-randomization ]Did the participant discontinue trazodone at a higher rate than placebo?
- 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
- 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)
- Medication Satisfaction [ Time Frame: 14-16 days post-randomization ]Treatment Satisfaction Questionnaire for Medications version II overall and subscale scores
- side-effect profile [ Time Frame: 14-16 days post-randomization ]participant-reported side effects of study drug
- sleepiness [ Time Frame: 14-16 days post-randomization ]Epworth Sleepiness Scale
- insomnia [ Time Frame: 14-16 days post-randomization ]Insomnia Severity Index
- general self-efficacy [ Time Frame: 14-16 days post-randomization ]General Self-Efficacy Scale
- depression [ Time Frame: 14-16 days post-randomization ]Clinically Useful Depression Outcome Scale (CUDOS)
- anxiety [ Time Frame: 14-16 days post-randomization ]Clinically Useful Anxiety Outcome Scale (CUXOS)
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
|United States, Ohio|
|Louis Stokes Cleveland VA Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Kingman P Strohl, MD||Louis Stokes Cleveland VA Medical Center|