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NCT Number: NCT06281756

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

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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Key information

Conditions

Insomnia Blood Pressure Blood Pressure, High Cardiovascular Diseases Dyssomnias Hypertension Insomnia Chronic Insomnia, Primary Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Université Laval, Québec, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Body Mass Index (BMI) 18.5 kg/m2 and higher

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
  • History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, or was not treated with surgery or weight loss.
  • Started new or changed treatment for sleep apnea in the past three months
  • 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
  • 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

Treatment and study plan

Cognitive Behavioral Treatment for Insomnia (CBT-I)

Behavioral

Subjects will receive therapy for 8 weeks

Trazodone

Drug

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

Placebo

Other

Non-remitting subjects will receive placebo for 8 weeks

Primary outcomes

  1. Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)

    Time frame: 9 weeks

    Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe

  2. Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)

    Time frame: 9 weeks

    Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe

  3. Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment

    Time frame: 35 weeks

    Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe

Secondary outcomes

  1. Insomnia Severity Index (ISI) Score following CBT-I

    Time frame: 9 weeks

    0-28, with 0 being mild and 28 being severe

  2. Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)

    Time frame: 9 weeks

    Polysomnography (PSG) Sleep efficiency measured as a percentage of time asleep during sleep study

  3. Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)

    Time frame: 9 weeks

    Actigraphy Sleep efficiency measured as estimated sleep time at home (2 week period)

  4. Evening Cortisol levels following CBT-I

    Time frame: 9 weeks

    Cortisol levels measured in saliva collected following CBT-I

  5. Insomnia Severity Index (ISI) Score following RCT

    Time frame: 9 weeks

    0-28, with 0 being mild and 28 being severe

  6. PSG Total Sleep Time (TST) following RCT

    Time frame: 9 weeks

    PSG Total Sleep Time measured in minutes asleep during sleep study following RCT

  7. Actigraphy Total Sleep Time (TST) following RCT

    Time frame: 9 weeks

    Actigraphy Total Sleep Time measured in minutes asleep during home study following RCT

  8. Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP)

    Time frame: 9 weeks

    Morning SBP Blood Pressure Readings measured at home (7 day period)

  9. Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP)

    Time frame: 9 weeks

    Morning DBP Blood Pressure Readings measured at home (7 day period)

  10. Evening Cortisol levels following RCT

    Time frame: 9 weeks

    Cortisol levels measured in saliva collected following RCT

  11. Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment

    Time frame: 35 weeks

    Cortisol levels measured in saliva 6 months following CBT-I Or RCT Treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Carrie Criley

CONTACT

[email protected]

717-531-4123

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 28, 2024
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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