InsomniaPhase 4DORMINCT03265951
Ramelteon for Complex Insomnia in Veterans With PTSD
A Phase 4 study testing Ramelteon in people with Insomnia, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Ramelteon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 30 Jun 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Medical Center in Buffalo
Buffalo, New York, 14215
About this study
Official title: A Pilot, Randomized, Double-blind, Placebo Controlled, Trial of Ramelteon for CPAP Non-Adherent Veterans With PTSD and Complex Insomnia
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Ramelteon, Usual Care
- Keywords
- sleep apnea, PTSD
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Apnea Syndromes, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamelteonDrug
Also called Rozerem
8 mg once daily administered within 30 minutes of bedtime
Usual CareOther
education brochure about sleep hygiene
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon | Active comparator | Ramelteon 8 mg po at bedtime Receives: Drug: Ramelteon |
| Usual care | Placebo comparator | education brochure about sleep hygiene Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
Quality of life
Measured: 12 weeks post randomization
Secondary outcomes (3)
PCL-5
PTSD Checklist
Measured: 12 weeks post randomization
ISI
Insomnia Severity Index
Measured: 12 weeks post randomization
CPAP adherence
CPAP adherence
Measured: 12 weeks post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Jan 2018
- Primary completion30 Sep 2019
- Study completion30 Jun 2020
Why it stopped: Lack of response
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- The VA Western New York Healthcare System
- Responsible party
- Principal investigator, Ali El Solh, State University of New York at Buffalo
- Investigators
- Ali El Solh, MD, Principal investigator, The VA Western New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265951
- Sponsor's protocol ID
- RF-1070471
- Acronym
- DORMI
- Status last verified
- Oct 2020
- First submitted
- 25 Aug 2017
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Randomized, Double-blind, Placebo Controlled, Trial of Ramelteon for CPAP Non-Adherent Veterans With PTSD and Complex Insomnia
- ClinicalTrials.gov ID
- NCT03265951
- Acronym / sponsor ID
- DORMI / RF-1070471
- Conditions
- Insomnia
- Keywords
- sleep apnea, PTSD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of response
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- The VA Western New York Healthcare System
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ramelteon | Active comparator | Drug: RamelteonRamelteon 8 mg po at bedtime |
| Usual care | Placebo comparator | Other: Usual Careeducation brochure about sleep hygiene |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- Medical:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamelteonAlso: Rozerem8 mg once daily administered within 30 minutes of bedtime | Drug | Ramelteon |
| Usual Careeducation brochure about sleep hygiene | Other | Usual care |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: 12 weeks post randomization
Quality of life
3 secondary outcomes
PCL-5
Time frame: 12 weeks post randomization
ISI
Time frame: 12 weeks post randomization
CPAP adherence
Time frame: 12 weeks post randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali El Solh, MD principal investigator
The VA Western New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramelteon in people with Insomnia, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (time frame: 12 weeks post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.