WithdrawnPhase 4

Ramelteon for Complex Insomnia in Veterans With PTSD

Stopped: Lack of response

United States0Started 2018-01-01

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 si…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pittsburgh Sleep Quality Index

Timeframe: 12 weeks post randomization

Trial details

NCT IDNCT03265951

SponsorState University of New York at Buffalo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-30

View on ClinicalTrials.gov More Insomnia trials