Phase
Condition
Stress
Vascular Diseases
Insomnia
Treatment
Cognitive Behavioral Treatment for Insomnia (CBT-I)
Trazodone
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 or older
Able to read and effectively communicate in English at the United States sites orable to read and effectively communicate in English or French at the Canadian site.
Meets criteria for chronic insomnia
Body Mass Index (BMI) 18.5 kg/m2 and higher
Exclusion
Exclusion Criteria:
Age < 18
Unable to read and effectively communicate in English at the United States sites orable to read and effectively communicate in English or French at the Canadian site.
Unwilling to share email address/cell phone number to accept survey links.
Life time diagnosis of psychotic or bipolar disorder
Current use of supplemental oxygen for the treatment of sleep apnea
History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currentlytreated with Positive Airway Pressure (PAP) therapy, an oral device or an implanteddevice, or was not treated with surgery or weight loss.
Started new or changed treatment for sleep apnea in the past three months
Does not meet criteria for chronic insomnia
Meets criteria for narcolepsy or hypersomnia disorder
Meets criteria for circadian rhythm disorder (including night shift work)
Unstable medical conditions that would make participation unsafe or unfeasible
Falls resulting in hospitalization, significant injury or fracture within past 12months
2 hospitalizations or emergency room visits within past 12 months for chronicconditions
Active chemotherapy or radiation therapy for cancer
Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency,chronic heart failure
Does not agree to refrain from other treatments for insomnia beyond what is offeredin this study
BMI less than 18.5
Substance abuse or dependence in the past 12 months
Current use of prescription or over the counter medications taken for sleep greaterthan 2 times per week
Current use of systemic corticosteroids or opiate medications
Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to usebirth control for the length of the study
Current use of medications contraindicated with trazodone
Sleep apnea or periodic leg movement disorder as determined by sleep study
Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110mmHg
EKG corrected QT interval greater than or equal to 500 ms
Study Design
Connect with a study center
Université Laval
Quebec, G1V 0A6
CanadaActive - Recruiting
National Jewish Health
Denver, Colorado 80206-2761
United StatesActive - Recruiting
Penn State University
Hershey, Pennsylvania 17033
United StatesActive - Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania 15213-3203
United StatesActive - Recruiting
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