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Ramelteon for Complex Insomnia in Veterans With PTSD (DORMI)

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ClinicalTrials.gov Identifier: NCT03265951
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
The VA Western New York Healthcare System
Information provided by (Responsible Party):
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)
Estimated Enrollment : 32 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
Estimated Primary Completion Date : September 30, 2019
Estimated 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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03265951


Contacts
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Contact: Ali El Solh, MD 7169979336 solh@buffalo.edu

Locations
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United States, New York
Veterans Affairs Medical Center in Buffalo Recruiting
Buffalo, New York, United States, 14215
Contact: Ali El-Solh, MD, MPH    716-862-8622    solh@buffalo.edu   
Sponsors and Collaborators
State University of New York at Buffalo
The VA Western New York Healthcare System
Investigators
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Principal Investigator: Ali El Solh, MD The VA Western New York

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Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT03265951     History of Changes
Other Study ID Numbers: RF-1070471
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
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 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
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders