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Ramelteon for Complex Insomnia in Veterans With PTSD (DORMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03265951
Recruitment Status : Withdrawn (Lack of response)
First Posted : August 29, 2017
Last Update Posted : April 9, 2021
The VA Western New York Healthcare System
Information provided by (Responsible Party):
Ali El Solh, State University of New York at Buffalo

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
Insomnia Drug: Ramelteon Other: Usual Care 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.

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Study Type : Interventional  (Clinical Trial)
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 : January 1, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ramelteon

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 Name: Rozerem

Placebo Comparator: Usual care
education brochure about sleep hygiene
Other: Usual Care
education brochure about sleep hygiene

Primary Outcome Measures :
  1. Pittsburgh Sleep Quality Index [ Time Frame: 12 weeks post randomization ]
    Quality of life

Secondary Outcome Measures :
  1. PCL-5 [ Time Frame: 12 weeks post randomization ]
    PTSD Checklist

  2. ISI [ Time Frame: 12 weeks post randomization ]
    Insomnia Severity Index

  3. CPAP adherence [ Time Frame: 12 weeks post randomization ]
    CPAP adherence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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


  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03265951

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United States, New York
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
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Principal Investigator: Ali El Solh, MD The VA Western New York
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Responsible Party: Ali El Solh, Principal Investigator, State University of New York at Buffalo Identifier: NCT03265951    
Other Study ID Numbers: RF-1070471
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, State University of New York at Buffalo:
sleep apnea, PTSD
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders