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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3HL161342-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo | Placebo Comparator | Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks. |
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| Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone | Active Comparator | Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Treatment for Insomnia (CBT-I) | Behavioral | Subjects will receive therapy for 8 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I) | Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe | 9 weeks |
| Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT) | Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe | 9 weeks |
| Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment | Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe | 35 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) Score following CBT-I | 0-28, with 0 being mild and 28 being severe | 9 weeks |
| Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carrie Criley | Contact | 717-531-4123 | ccriley@pennstatehealth.psu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexandros Vgontzas, MD | Professor, Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Recruiting | Denver | Colorado | 80206-2761 | United States |
The investigators have extensive experience preparing data and documentation to be available for public. They agree to abide by the principles for sharing research resources described by the National Heart, Lung, Blood Institute (NHLBI). A copy of the data will be uploaded to the NHLBI Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) repository. The datasets will not include any personal identifiers related to participants or clinical sites. Dates will be de-identified through a date-shifting algorithm to mask actual dates while maintaining a relation to the epoch in which events occurred. Data tables will be exported in comma-separated format, readable by statistical software. Variable dictionaries and code books, detailing variable description, format, value domain and labels, will be produced. Raw data files for polysomnogram/actigraphy/cortisol will also be made available, ensuring that data are linkable to study data and data are de-identified.
Data collected for aim 1 (an observational study) and aim 2 (a randomized clinical trial) will be made available no more than 3 years after the completion of the last follow-up assessment. Data will be submitted to the Program Officer and uploaded to the NHLBI BioLINCC repository no later than 3 years after the end of clinical activity or 2 years after the main outcomes paper is published, whichever comes first.
NHLBI BioLINCC repository
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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.
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Both prescribing physicians and participants will be blind to phenotype and treatment groups.
| Trazodone | Drug | Non-remitting subjects will receive Trazodone (dosage) for 8 weeks |
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| Placebo | Other | Non-remitting subjects will receive placebo for 8 weeks |
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Polysomnography (PSG) Sleep efficiency measured as a percentage of time asleep during sleep study
| 9 weeks |
| Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) | Actigraphy Sleep efficiency measured as estimated sleep time at home (2 week period) | 9 weeks |
| Evening Cortisol levels following CBT-I | Cortisol levels measured in saliva collected following CBT-I | 9 weeks |
| Insomnia Severity Index (ISI) Score following RCT | 0-28, with 0 being mild and 28 being severe | 9 weeks |
| PSG Total Sleep Time (TST) following RCT | PSG Total Sleep Time measured in minutes asleep during sleep study following RCT | 9 weeks |
| Actigraphy Total Sleep Time (TST) following RCT | Actigraphy Total Sleep Time measured in minutes asleep during home study following RCT | 9 weeks |
| Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP) | Morning SBP Blood Pressure Readings measured at home (7 day period) | 9 weeks |
| Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP) | Morning DBP Blood Pressure Readings measured at home (7 day period) | 9 weeks |
| Evening Cortisol levels following RCT | Cortisol levels measured in saliva collected following RCT | 9 weeks |
| Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment | Cortisol levels measured in saliva 6 months following CBT-I Or RCT Treatment | 35 weeks |
| Penn State University | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213-3203 | United States |
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| Université Laval | Recruiting | Québec | Quebec | G1V 0A6 | Canada |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D006973 | Hypertension |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014196 | Trazodone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011728 | Pyridones |
| D011725 | Pyridines |
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