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The purpose of this study is to evaluate the effect of a 3 month medication trial of Trazodone versus 3 months of Cognitive Behavioral Therapy (CBT) in patients with chronic insomnia.
Participants with chronic insomnia associated with objective short sleep duration will be recruited to participate in a 3 month clinical trial on the efficacy of trazodone versus CBT, with a 6 month follow up. The primary outcome measure will be objective sleep duration as measured by both actigraphy and polysomnography. The secondary outcome measure will be subjective severity of sleep disturbance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trazodone | Active Comparator |
| |
| Cognitive Behavioral Therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trazodone | Drug | 50 mg once a day, for 3 months |
| |
| Cognitive Behavioral Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months) | Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and post treatment (3 months) | Baseline to Post Treatment (3 months) |
| Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months) | Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and follow up (9 months) | Baseline to follow up (9 months) |
| Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months) | Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and Post Treatment (3 months) | Baseline to Post Treatment (3 months) |
| Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months) | Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and follow up (9 months) | Baseline to follow up (9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months | The Insomnia Severity Index (ISI) was used to measure the change in severity of sleep disturbance at baseline to post treatment (3 months). The ISI is composed of 7 items each rated on a scale of 0-4. The total score was calculated by adding the individual item scores. The total ISI scale score ranged from 0-28 with higher total scores indicating a higher severity of insomnia symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandros N Vgontzas, MD | Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20857861 | Background | Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Basta M, Fernandez-Mendoza J, Bixler EO. Insomnia with short sleep duration and mortality: the Penn State cohort. Sleep. 2010 Sep;33(9):1159-64. doi: 10.1093/sleep/33.9.1159. | |
| 19641160 | Background | Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Bixler EO. Insomnia with objective short sleep duration is associated with type 2 diabetes: A population-based study. Diabetes Care. 2009 Nov;32(11):1980-5. doi: 10.2337/dc09-0284. Epub 2009 Jul 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trazodone | Trazodone: 50 mg once a day, for 3 months |
| FG001 | Cognitive Behavioral Therapy | Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trazodone | Trazodone: 50 mg once a day, for 3 months |
| BG001 | Cognitive Behavioral Therapy | Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months) | Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and post treatment (3 months) | Objective Short Sleepers defined by 2 week actigraphy sleep duration measurement | Posted | Mean | Standard Deviation | minutes | Baseline to Post Treatment (3 months) |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trazodone | Trazodone: 50 mg once a day, for 3 months | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexandros Vgontzas | Penn State University College of Medicine | 717 531-7278 | vgontzas@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2019 | May 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014196 | Trazodone |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011728 | Pyridones |
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| Behavioral |
The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis. |
|
| Baseline to Post Treatment (3 months) |
| Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months | The Insomnia Severity Index (ISI) was used to measure the change in severity of sleep disturbance at baseline to Follow Up (9 months). The ISI is composed of 7 items each rated on a scale of 0-4. The total score was calculated by adding the individual item scores. The total ISI scale score ranged from 0-28 with higher total scores indicating a higher severity of insomnia symptoms. | Baseline to follow up (9 months) |
| 19413143 | Background | Vgontzas AN, Liao D, Bixler EO, Chrousos GP, Vela-Bueno A. Insomnia with objective short sleep duration is associated with a high risk for hypertension. Sleep. 2009 Apr;32(4):491-7. doi: 10.1093/sleep/32.4.491. |
| 11502812 | Background | Vgontzas AN, Bixler EO, Lin HM, Prolo P, Mastorakos G, Vela-Bueno A, Kales A, Chrousos GP. Chronic insomnia is associated with nyctohemeral activation of the hypothalamic-pituitary-adrenal axis: clinical implications. J Clin Endocrinol Metab. 2001 Aug;86(8):3787-94. doi: 10.1210/jcem.86.8.7778. |
| 20394314 | Background | Fernandez-Mendoza J, Calhoun S, Bixler EO, Pejovic S, Karataraki M, Liao D, Vela-Bueno A, Ramos-Platon MJ, Sauder KA, Vgontzas AN. Insomnia with objective short sleep duration is associated with deficits in neuropsychological performance: a general population study. Sleep. 2010 Apr;33(4):459-65. doi: 10.1093/sleep/33.4.459. |
| 20978224 | Background | Fernandez-Mendoza J, Calhoun SL, Bixler EO, Karataraki M, Liao D, Vela-Bueno A, Jose Ramos-Platon M, Sauder KA, Basta M, Vgontzas AN. Sleep misperception and chronic insomnia in the general population: role of objective sleep duration and psychological profiles. Psychosom Med. 2011 Jan;73(1):88-97. doi: 10.1097/PSY.0b013e3181fe365a. Epub 2010 Oct 26. |
| 33675113 | Derived | Li Y, Vgontzas AN, Fernandez-Mendoza J, Fang J, Puzino K, Bixler EO. Effect of trazodone versus cognitive-behavioural treatment on high- and slow-frequency activity during non-rapid eye movement sleep in chronic insomnia: A pilot, randomized clinical trial. J Sleep Res. 2021 Oct;30(5):e13324. doi: 10.1111/jsr.13324. Epub 2021 Mar 5. |
| 32780015 | Derived | Vgontzas AN, Puzino K, Fernandez-Mendoza J, Krishnamurthy VB, Basta M, Bixler EO. Effects of trazodone versus cognitive behavioral therapy in the insomnia with short sleep duration phenotype: a preliminary study. J Clin Sleep Med. 2020 Dec 15;16(12):2009-2019. doi: 10.5664/jcsm.8740. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Insomnia Severity Index | The Insomnia Severity Index (ISI) a self completed questionnaire was used to measure the severity of sleep disturbance. The ISI is composed of 7 items each rated on a scale of 0-4. The total score was calculated by adding the individual item scores. The total ISI Scale can range from 0-28 with higher total scores indicating a higher severity of insomnia symptoms and sleep disturbance. | Mean | Standard Deviation | score on a scale |
|
|
|
| Primary | Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months) | Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and follow up (9 months) | From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis. | Posted | Mean | Standard Deviation | minutes | Baseline to follow up (9 months) |
|
|
|
| Primary | Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months) | Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and Post Treatment (3 months) | From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis. | Posted | Mean | Standard Deviation | minutes | Baseline to Post Treatment (3 months) |
|
|
|
| Primary | Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months) | Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and follow up (9 months) | From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis. | Posted | Mean | Standard Deviation | minutes | Baseline to follow up (9 months) |
|
|
|
| Secondary | Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months | The Insomnia Severity Index (ISI) was used to measure the change in severity of sleep disturbance at baseline to post treatment (3 months). The ISI is composed of 7 items each rated on a scale of 0-4. The total score was calculated by adding the individual item scores. The total ISI scale score ranged from 0-28 with higher total scores indicating a higher severity of insomnia symptoms. | From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Post Treatment (3 months) |
|
|
|
| Secondary | Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months | The Insomnia Severity Index (ISI) was used to measure the change in severity of sleep disturbance at baseline to Follow Up (9 months). The ISI is composed of 7 items each rated on a scale of 0-4. The total score was calculated by adding the individual item scores. The total ISI scale score ranged from 0-28 with higher total scores indicating a higher severity of insomnia symptoms. | From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to follow up (9 months) |
|
|
|
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Cognitive Behavioral Therapy | Cognitive Behavioral Therapy: The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D001523 |
| Mental Disorders |
| D011725 |
| Pyridines |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |