Trazodone Dose Tolerance and APAP Adherence

NCT02945644 | Suspended Phase 1 DMC FDA Drug

• 1 other identifier: 16025-H17
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

obstructive sleep apnea; trazodone; positive airway pressure; adherence

Outcome Measures

Primary Outcomes (1)

• Discontinuation rate by participant

  Did the participant discontinue trazodone at a higher rate than placebo?

  14-16 days post-randomization

Secondary Outcomes (9)

• 3 month APAP adherence

  3 months post-randomization assessing 30 days before this 3 month period

• Respiratory patterning

  14-16 days post-randomization

• Medication Satisfaction

  14-16 days post-randomization

• side-effect profile

  14-16 days post-randomization

• sleepiness

  14-16 days post-randomization

Study Arms (3)

Placebo

PLACEBO COMPARATOR

pill filled with inert material

Drug: Placebo

Trazodone 50mg

ACTIVE COMPARATOR

Drug: Trazodone

Trazodone 100mg

ACTIVE COMPARATOR

Drug: Trazodone

Interventions

Trazodone DRUG

take at bedtime for 14 days

Also known as: oleptro, Desyrel

Trazodone 100mg; Trazodone 50mg

Placebo DRUG

take at bedtime for 14 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Louis Stokes VA Medical Center: lead

Study Sites (1)

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Study Officials

• Kingman P Strohl, MD

  Louis Stokes Cleveland VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 26, 2016
• Study Start: February 13, 2017
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)