Insomnia
Conditions
Keywords
sleep apnea, PTSD
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.
Interventions
DRUGRamelteon
8 mg once daily administered within 30 minutes of bedtime
OTHERUsual Care
education brochure about sleep hygiene
Sponsors
The VA Western New York Healthcare System
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index | 12 weeks post randomization | Quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PCL-5 | 12 weeks post randomization | PTSD Checklist |
| ISI | 12 weeks post randomization | Insomnia Severity Index |
| CPAP adherence | 12 weeks post randomization | CPAP adherence |
Countries
United States
Outcome results
None listed