Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia

Insomnia Clinical Trial

Official title:

Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort/Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06281756
• Other study ID #: STUDY00022285
• Secondary ID: 1UG3HL161342-01A
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 14, 2024
• Est. completion date: February 2028

Study information

• Verified date: June 2024
• Source: Milton S. Hershey Medical Center
• Contact: Carrie Criley
• Phone: 717-531-4123
• Email: ccriley[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: February 2028
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Takes anti-hypertensive medication (same regimen for at least 3 months); or elevated blood pressure, defined as seated SBP =120 mmHg or DBP =80 mmHg, measured in the research clinic

• Body Mass Index (BMI) 18.5-<40 kg/m2

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

• Current use of Positive Airway Pressure (PAP) therapy

• 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 or greater than 40

• 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

Related Conditions & MeSH terms

• Blood Pressure
• Blood Pressure, High
• Hypertension
• Insomnia
• Insomnia Chronic
• Insomnia, Primary
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioral Treatment for Insomnia (CBT-I)
Subjects will receive therapy for 8 weeks

Drug:
• Trazodone
Non-remitting subjects will receive Trazodone (dosage) for 8 weeks

Other:
• Placebo
Non-remitting subjects will receive placebo for 8 weeks

Locations

Country	Name	City	State
Canada	Université Laval	Quebec
United States	National Jewish Health	Denver	Colorado
United States	Penn State University	Hershey	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	Insomnia Severity Index (ISI) Score following CBT-I	0-28, with 0 being mild and 28 being severe	9 weeks
Secondary	Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)	Polysomnography (PSG) Sleep efficiency measured as a percentage of time asleep during sleep study	9 weeks
Secondary	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
Secondary	Evening Cortisol levels following CBT-I	Cortisol levels measured in saliva collected following CBT-I	9 weeks
Secondary	Insomnia Severity Index (ISI) Score following RCT	0-28, with 0 being mild and 28 being severe	9 weeks
Secondary	PSG Total Sleep Time (TST) following RCT	PSG Total Sleep Time measured in minutes asleep during sleep study following RCT	9 weeks
Secondary	Actigraphy Total Sleep Time (TST) following RCT	Actigraphy Total Sleep Time measured in minutes asleep during home study following RCT	9 weeks
Secondary	Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP)	Morning SBP Blood Pressure Readings measured at home (7 day period)	9 weeks
Secondary	Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP)	Morning DBP Blood Pressure Readings measured at home (7 day period)	9 weeks
Secondary	Evening Cortisol levels following RCT	Cortisol levels measured in saliva collected following RCT	9 weeks
Secondary	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