Blood Pressure, Blood Pressure, High, Insomnia, Insomnia Chronic, Insomnia, Primary
Conditions
Keywords
sleep, sleep disorder, insomnia
Brief summary
Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.
Interventions
Subjects will receive therapy for 8 weeks
DRUGTrazodone
Non-remitting subjects will receive Trazodone (dosage) for 8 weeks
OTHERPlacebo
Non-remitting subjects will receive placebo for 8 weeks
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Both prescribing physicians and participants will be blind to phenotype and treatment groups.
Intervention model description
A 4-site (Hershey, Pennsylvania; Pittsburgh, Pennsylvania; Denver, Colorado; and Quebec, Canada) cohort study will examine the effect of CBT-I as a recommended first-line treatment for insomnia. This will be followed by a placebo-controlled randomized controlled trial (RCT) in those who do not remit in the Cohort Study. The subsequent RCT will compare the efficacy of trazodone vs. placebo among CBT-I non-remitters.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Able to read and effectively communicate in English at the United States sites or able 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 criteria
* Age \< 18 * Unable to read and effectively communicate in English at the United States sites or able 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 * History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, 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 12 months * 2 hospitalizations or emergency room visits within past 12 months for chronic conditions * 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 offered in 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 greater than 2 times per week * Current use of systemic corticosteroids or opiate medications * Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth 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 110 mmHg * EKG corrected QT interval greater than or equal to 500 ms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I) | 9 weeks | Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe |
| Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT) | 9 weeks | Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe |
| Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment | 35 weeks | Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evening Cortisol levels following CBT-I | 9 weeks | Cortisol levels measured in saliva collected following CBT-I |
| Insomnia Severity Index (ISI) Score following RCT | 9 weeks | 0-28, with 0 being mild and 28 being severe |
| PSG Total Sleep Time (TST) following RCT | 9 weeks | PSG Total Sleep Time measured in minutes asleep during sleep study following RCT |
| Actigraphy Total Sleep Time (TST) following RCT | 9 weeks | Actigraphy Total Sleep Time measured in minutes asleep during home study following RCT |
| Insomnia Severity Index (ISI) Score following CBT-I | 9 weeks | 0-28, with 0 being mild and 28 being severe |
| Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP) | 9 weeks | Morning DBP Blood Pressure Readings measured at home (7 day period) |
| Evening Cortisol levels following RCT | 9 weeks | Cortisol levels measured in saliva collected following RCT |
| Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment | 35 weeks | Cortisol levels measured in saliva 6 months following CBT-I Or RCT Treatment |
| Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP) | 9 weeks | Morning SBP Blood Pressure Readings measured at home (7 day period) |
| Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) | 9 weeks | Polysomnography (PSG) Sleep efficiency measured as a percentage of time asleep during sleep study |
| Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) | 9 weeks | Actigraphy Sleep efficiency measured as estimated sleep time at home (2 week period) |
Countries
Canada, United States
Contacts
Primary ContactCarrie Criley
Outcome results
None listed