Clinical trial NCT01348542: Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia
Official title: Efficacy of Trazodone vs. Cognitive Behavioral Therapy in Patients With Chronic Insomnia Associated With Objective Short Sleep Duration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Chronic Insomnia
Short Sleep Duration
Trazodone
Cognitive Behavioral Therapy
Efficacy
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2011-05-05
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Chronic insomnia with duration of more than 1 year
* Objective short sleep duration (\< 6 hours)
* BMI \< 39
* Ages 30-60
* Men \& Women

Exclusion Criteria:

* Major Mental Illness
* 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

Primary outcomes:
measure: Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months)
timeFrame: Baseline to Post Treatment (3 months)
measure: Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months)
timeFrame: Baseline to follow up (9 months)
measure: Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months)
timeFrame: Baseline to Post Treatment (3 months)
measure: Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months)
timeFrame: Baseline to follow up (9 months)
Secondary outcomes:
measure: Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months
timeFrame: Baseline to Post Treatment (3 months)
measure: Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months
timeFrame: Baseline to follow up (9 months)
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
name: Alexandros N Vgontzas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.