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Ramelteon for Complex Insomnia in Veterans With PTSD

NCT03265951 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2021-04-09

No results posted yet for this study

Summary

Obstructive sleep apnea is commonly reported in Veterans with post-traumatic stress disorder, which can potentiate symptoms of anxiety and depression, daytime symptoms and worsen nightmares. Continuous positive airway pressure is the most effective therapy but adherence to treatment is suboptimal. The overarching theme of the proposal is to compare usual care to Ramelteon, in a randomized, clinical trial, investigating the effectiveness of physiological versus pharmacological intervention on sleep quality of life, insomnia severity and CPAP adherence.

Conditions

Interventions

DRUG

Ramelteon

8 mg once daily administered within 30 minutes of bedtime

OTHER

Usual Care

education brochure about sleep hygiene

Sponsors & Collaborators

  • The VA Western New York Healthcare System

    collaborator FED

  • State University of New York at Buffalo

    lead OTHER

Principal Investigators

  • Ali El Solh, MD · The VA Western New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-09-30
Completion
2020-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03265951 on ClinicalTrials.gov