NCT03265951

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

April 9, 2021

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

August 25, 2017

Last Update Submit

April 8, 2021

Conditions

Insomnia

Keywords

sleep apnea, PTSD

Outcome Measures

Primary Outcomes (1)

  • Pittsburgh Sleep Quality Index

    Quality of life

    12 weeks post randomization

Secondary Outcomes (3)

  • PCL-5

    12 weeks post randomization

  • ISI

    12 weeks post randomization

  • CPAP adherence

    12 weeks post randomization

Study Arms (2)

Ramelteon

ACTIVE COMPARATOR

Ramelteon 8 mg po at bedtime

Drug: Ramelteon

Usual care

PLACEBO COMPARATOR

education brochure about sleep hygiene

Other: Usual Care

Interventions

RamelteonDRUG

8 mg once daily administered within 30 minutes of bedtime

Also known as: Rozerem
Ramelteon
Usual CareOTHER

education brochure about sleep hygiene

Usual care

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Affairs Medical Center in Buffalo

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Apnea SyndromesStress Disorders, Post-Traumatic

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersApneaRespiration DisordersRespiratory Tract DiseasesStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Ali El Solh, MD

    The VA Western New York

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2017

First Posted

August 29, 2017

Study Start

January 1, 2018

Primary Completion

September 30, 2019

Study Completion

June 30, 2020

Last Updated

April 9, 2021

Record last verified: 2020-10

Locations

US(1)