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Trazodone Dose Tolerance and APAP Adherence

2016-10-27 05:38:22 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Sleep Apnea, Obstructive

Intervention

Trazodone, Placebo

Location

Louis Stokes Cleveland VA Medical Center
Cleveland
Ohio
United States
44106

Status

Not yet recruiting

Source

Louis Stokes VA Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-27T05:38:22-0400

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A condition associated with multiple episodes of sleep apnea which are distinguished from obstructive sleep apnea (SLEEP APNEA, OBSTRUCTIVE) by the complete cessation of efforts to breathe. This disorder is associated with dysfunction of central nervous system centers that regulate respiration. This condition may be idiopathic (primary) or associated with lower brain stem lesions; chronic obstructive pulmonary disease (LUNG DISEASES, OBSTRUCTIVE); HEART FAILURE, CONGESTIVE; medication effect; and other conditions. Sleep maintenance is impaired, resulting in daytime hypersomnolence. Primary central sleep apnea is frequently associated with obstructive sleep apnea. When both forms are present the condition is referred to as mixed sleep apnea (see SLEEP APNEA SYNDROMES). (Adams et al., Principles of Neurology, 6th ed, p395; Neurol Clin 1996;14(3):611-28)

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HYPOVENTILATION syndrome in very obese persons with excessive ADIPOSE TISSUE around the ABDOMEN and DIAPHRAGM. It is characterized by diminished to absent ventilatory chemoresponsiveness; chronic HYPOXIA; HYPERCAPNIA; POLYCYTHEMIA; and long periods of sleep during day and night (HYPERSOMNOLENCE). It is a condition often related to OBSTRUCTIVE SLEEP APNEA but can occur separately.

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