Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT03265951
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03265951
Study Brief:
Protocol Section:
NCT03265951