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Ramelteon for Complex Insomnia in Veterans With PTSD (DORMI)

Primary Purpose

Insomnia

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ramelteon
Usual Care
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring sleep apnea, PTSD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veterans Affairs Medical Center in Buffalo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ramelteon

Usual care

Arm Description

Ramelteon 8 mg po at bedtime

education brochure about sleep hygiene

Outcomes

Primary Outcome Measures

Pittsburgh Sleep Quality Index
Quality of life

Secondary Outcome Measures

PCL-5
PTSD Checklist
ISI
Insomnia Severity Index
CPAP adherence
CPAP adherence

Full Information

First Posted
August 25, 2017
Last Updated
April 8, 2021
Sponsor
State University of New York at Buffalo
Collaborators
The VA Western New York Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT03265951
Brief Title
Ramelteon for Complex Insomnia in Veterans With PTSD
Acronym
DORMI
Official Title
A Pilot, Randomized, Double-blind, Placebo Controlled, Trial of Ramelteon for CPAP Non-Adherent Veterans With PTSD and Complex Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of response
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
The VA Western New York Healthcare System

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
sleep apnea, PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ramelteon
Arm Type
Active Comparator
Arm Description
Ramelteon 8 mg po at bedtime
Arm Title
Usual care
Arm Type
Placebo Comparator
Arm Description
education brochure about sleep hygiene
Intervention Type
Drug
Intervention Name(s)
Ramelteon
Other Intervention Name(s)
Rozerem
Intervention Description
8 mg once daily administered within 30 minutes of bedtime
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
education brochure about sleep hygiene
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
Quality of life
Time Frame
12 weeks post randomization
Secondary Outcome Measure Information:
Title
PCL-5
Description
PTSD Checklist
Time Frame
12 weeks post randomization
Title
ISI
Description
Insomnia Severity Index
Time Frame
12 weeks post randomization
Title
CPAP adherence
Description
CPAP adherence
Time Frame
12 weeks post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali El Solh, MD
Organizational Affiliation
The VA Western New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Medical Center in Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Ramelteon for Complex Insomnia in Veterans With PTSD

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