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DORMI: Ramelteon for Complex Insomnia in Veterans With PTSD

Sponsor
State University of New York at Buffalo (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03265951
Collaborator
The VA Western New York Healthcare System (U.S. Fed)
0
Enrollment
1
Location
2
Arms
29.9
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Despite the overall improvement in PTSD symptomatology with CPAP therapy, adherence to CPAP is far worse in Veterans with PTSD (41%) compared to the general population with OSA (70%). Among the factors associated with CPAP non-adherence is the coexistence of insomnia. Complex insomnia defined as the coexistence of comorbid insomnia ans OSA is a frequent diagnosis in military personnel with combat exposure. Similar to prior reports of patients with OSA without PTSD, comorbid insomnia can create a barrier to CPAP therapy. Ramelteon (TAK-375), approved by the Food and Drug Administration for the treatment of insomnia with sleep onset abnormalities, is a neurohormone that functions as a melatonin receptor agonist targeting the MT1 and MT2 receptors located in the suprachiasmatic nucleus of the hypothalamus which regulates the circadian rhythm of the 24-hour sleep-wake cycle.The goal is to test the hypothesis that the administration of insomnia therapy-ramelteon- significantly improves treatment outcomes in Veterans with PTSD and complex insomnia compared with placebo.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Pilot, Randomized, Double-blind, Placebo Controlled, Trial of Ramelteon for CPAP Non-Adherent Veterans With PTSD and Complex Insomnia
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Sep 30, 2019
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ramelteon

Ramelteon 8 mg po at bedtime

Drug: Ramelteon
8 mg once daily administered within 30 minutes of bedtime
Other Names:
  • Rozerem

    		•
    Placebo Comparator: Usual care

    education brochure about sleep hygiene

    Other: Usual Care
    education brochure about sleep hygiene

    Outcome Measures

    Primary Outcome Measures

    1. Pittsburgh Sleep Quality Index [12 weeks post randomization]

      Quality of life

    Secondary Outcome Measures

    1. PCL-5 [12 weeks post randomization]

      PTSD Checklist

    2. ISI [12 weeks post randomization]

      Insomnia Severity Index

    3. CPAP adherence [12 weeks post randomization]

      CPAP adherence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age ≥18 years and ≤70 years old

    • Diagnosis of PTSD as determined by the intake conducted through the PTSD Clinic or the Mental Health Clinic

    • Documented obstructive sleep apnea by polysomnography (AHI≥5 or more/hour)

    • CPAP non adherence defined as less than 70% of nights with >4h CPAP use despite addressing modifiable barriers for CPAP adherence

    • Psychotherapeutic treatment stable for at least 4 weeks prior to randomization

    • Capable of giving informed consent

    Exclusion Criteria:

    • Medical:

    • Acute or unstable chronic medical illness

    • History of narcolepsy and/or cataplexy Use of any of these medications: Fluvoxamine, fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); cimetidine (Tagamet); clarithromycin (Biaxin); fluoroquinolones including ciprofloxacin, levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), others; HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); nefazodone; rifampin

    • Treatment for seizure disorders

    • Pregnant or lactating

    • History of clinically significant hepatic impairment

    • History of hypersensitivity, intolerance, or contraindication to ramelteon

    • Unwilling to try or use CPAP

    Psychiatric/Behavioral:

    • Diagnosis of current schizophrenia or schizoaffective disorder

    • Diagnosis of a substance dependence/abuse disorder in the past year

    • Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others

    • Diagnosis of bipolar disorder

    • Consumption of more than two alcoholic beverages per night

    • Receiving behavioral or pharmacological treatment for insomnia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Veterans Affairs Medical Center in Buffalo Buffalo New York United States 14215

    Sponsors and Collaborators

    • State University of New York at Buffalo
    • The VA Western New York Healthcare System

    Investigators

    • Principal Investigator: Ali El Solh, MD, The VA Western New York

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ali El Solh, Principal Investigator, State University of New York at Buffalo
    ClinicalTrials.gov Identifier:
    NCT03265951
    Other Study ID Numbers:
    • RF-1070471
    First Posted:
    Aug 29, 2017
    Last Update Posted:
    Apr 9, 2021
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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 Ali El Solh, Principal Investigator, State University of New York at Buffalo
    sleep apnea, PTSD
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders

    Study Results

    No Results Posted as of Apr 9, 2021