Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia
NCT ID: NCT01348542
Last Updated: 2020-02-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2011-04-30
2018-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trazodone
Trazodone
50 mg once a day, for 3 months
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.
Interventions
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Trazodone
50 mg once a day, for 3 months
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.
Eligibility Criteria
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Inclusion Criteria
* Objective short sleep duration (\< 6 hours)
* BMI \< 39
* Ages 30-60
* Men \& Women
Exclusion Criteria
* Substance Abuse/Dependence
* Sleep Apnea
* Periodic Limb Movement Disorder
* Shift Work or circadian disorders
* Diabetes
* Chronic Renal Failure, Hepatic Insufficiency, Chronic Heart Failure
* Current Use of hypnotics or sleep inducing sedative antidepressants
30 Years
60 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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Alexandros Vgontzas
Principal Investigator
Principal Investigators
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Alexandros N Vgontzas, MD
Role: PRINCIPAL_INVESTIGATOR
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Locations
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Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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35933
Identifier Type: -
Identifier Source: org_study_id
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