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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The objective of this study is to elucidate the potential mechanisms responsible for the increased risk of cardiovascular disease among patients with hypertension and comorbid insomnia.
The investigators propose to utilize a behavioral intervention to manipulate sleep quality in 150 adults with hypertension and comorbid insomnia, who will receive a 6-week Cognitive Behavioral therapy for Insomnia (CBT-I) intervention, which has been shown to markedly improve sleep quality and promote consolidated sleep in approximately 60% of those treated. A lowering of nighttime blood pressure is one of several proposed mechanisms to be examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Other | Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Behavioral | 6-week CBT-I therapy to help improve sleep quality |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Pressure During the Nighttime Sleep Period | Average nighttime blood pressure measured before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Baseline, 6 months post-intervention |
| Change in Sleep During the Nighttime Sleep Period as Measured by Sleep Diary | Sleep efficiency (percent-time asleep during the sleep period) measured before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Baseline, 6 months post-intervention |
| Change in Sleep During the Nighttime Sleep Period as Measured by Actigraphy | Sleep efficiency (percent-time asleep during the sleep period) measured by actigraphy before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Baseline, 6 months post-intervention |
| Changes in Insomnia Severity as Measured by the Insomnia Severity Index (ISI) | The ISI is a seven-item questionnaire where respondents rate each element using Likert-type scales. Responses can range from 0 to 4 and are summed for a total score range of 0 to 28, where higher scores indicate more acute symptoms of insomnia. | Baseline, 6 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Awake Blood Pressure | Average awake blood pressure (mm Hg) measured by 24 hour ambulatory blood pressure monitoring before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Baseline, 6 months post-intervention |
| Change in Nighttime Blood Pressure Dip Percentage |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiac Function | Cardiac left ventricular strain (%) before and after CBT-I | 6 week, 6 months post intervention |
| Change in Cardiac Structure | Cardiac left ventricular mass (g m^-2.7) before and after CBT-I |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Sherwood, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38468418 | Derived | Sherwood A, Ulmer C, Wu JQ, Blumenthal JA, Herold E, Smith PJ, Koch GG, Johnson K, Viera A, Edinger J, Hinderliter A. Cognitive behavior therapy for insomnia for untreated hypertension with comorbid insomnia disorder: The SLEEPRIGHT clinical trial. J Clin Hypertens (Greenwich). 2024 Apr;26(4):441-447. doi: 10.1111/jch.14763. Epub 2024 Mar 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral Therapy for Insomnia | Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each). Cognitive Behavioral Therapy for Insomnia (CBT-I): 6-week CBT-I therapy to help improve sleep quality |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavioral Therapy for Insomnia | Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each). Cognitive Behavioral Therapy for Insomnia (CBT-I): 6-week CBT-I therapy to help improve sleep quality |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Blood Pressure During the Nighttime Sleep Period | Average nighttime blood pressure measured before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Participants who completed the study. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline, 6 months post-intervention |
|
|
Up to 6 months post-intervention
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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 | Cognitive Behavioral Therapy for Insomnia | Cognitive Behavioral Therapy for Insomnia (CBT-I) 6 sessions of Cognitive Behavioral Training for Insomnia (1 hour each). Cognitive Behavioral Therapy for Insomnia (CBT-I): 6-week CBT-I therapy to help improve sleep quality |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Sherwood, Ph.D. | Duke University | 919-684-8835 | andrew.sherwood@duke.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 | Nov 29, 2023 | Dec 19, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2021 | Feb 19, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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All participants will receive the Cognitive Behavioral Therapy for Insomnia
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Average percent change in blood pressure before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). |
| Baseline, 6 months post-intervention |
| Change in Vascular Endothelial Function | Percent dilation of the brachial artery to reactive hyperemia measured by flow mediated dilation before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Baseline, 6 months post-intervention |
| Change in Arterial Stiffness | Pulse wave velocity (m/s) of the descending aorta measured using the Complior system before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Baseline, 6 months post-intervention |
| Change in Lipid Profile - HDL (High-Density Lipoprotein), LDL (Low-Density Lipoprotein), and Triglycerides | Lipids (HDL, LDL, and Triglycerides) from fasting venous blood draw measured before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Baseline, 6 months post-intervention |
| Change in Nighttime Sympathetic Nervous System Activity | Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) before and after CBT-I. Adjusted via creatinine normalization by dividing by the urine creatinine concentration. | Pre-CBT-I Baseline (6 weeks) to post-CBT-I (12 weeks) |
| Change in Sleep Fragmentation During the Nighttime Sleep Period | Sleep Fragmentation Index (SFI) measured by actigraphy before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 weeks post-intervention). The SFI measures how often sleep is interrupted by brief awakenings or shifts between sleep stages, calculated by dividing the number of these transitions by total sleep time | Baseline, 6 weeks post-intervention |
| Change in Subjective Sleep Quality | Subjective Sleep Quality measured by Pittsburgh Sleep Quality Index (PSQI) before and after CBT-I. The PSQI is a widely used, self-report questionnaire that assesses sleep quality and disturbances over a one-month period, identifying factors like sleep latency (time to fall asleep), duration, disturbances, medication use, and daytime dysfunction, yielding a global score (0-21) where higher scores indicate poorer sleep. | Pre-CBT-I baseline (6 week) to post-CBT-I (12 weeks) |
| Change in Clinic Blood Pressure | Average office seated blood pressure taken by automated clinic blood pressure monitor after 5 minutes rest and based on the average of 3 readings taken at one minute intervals (mm Hg) | Baseline to 6 months post-intervention |
| 6 week, 6 months post intervention |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Change in Sleep During the Nighttime Sleep Period as Measured by Sleep Diary | Sleep efficiency (percent-time asleep during the sleep period) measured before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Participants who completed the study. | Posted | Mean | 95% Confidence Interval | percentage of time asleep | Baseline, 6 months post-intervention |
|
|
|
|
| Primary | Change in Sleep During the Nighttime Sleep Period as Measured by Actigraphy | Sleep efficiency (percent-time asleep during the sleep period) measured by actigraphy before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Participants who completed the study. | Posted | Mean | 95% Confidence Interval | percentage of time asleep | Baseline, 6 months post-intervention |
|
|
|
|
| Primary | Changes in Insomnia Severity as Measured by the Insomnia Severity Index (ISI) | The ISI is a seven-item questionnaire where respondents rate each element using Likert-type scales. Responses can range from 0 to 4 and are summed for a total score range of 0 to 28, where higher scores indicate more acute symptoms of insomnia. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 6 months post-intervention |
|
|
|
|
| Secondary | Change in Awake Blood Pressure | Average awake blood pressure (mm Hg) measured by 24 hour ambulatory blood pressure monitoring before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Posted | Mean | 95% Confidence Interval | mmHg | Baseline, 6 months post-intervention |
|
|
|
|
| Secondary | Change in Nighttime Blood Pressure Dip Percentage | Average percent change in blood pressure before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Posted | Mean | 95% Confidence Interval | percentage points | Baseline, 6 months post-intervention |
|
|
|
|
| Secondary | Change in Vascular Endothelial Function | Percent dilation of the brachial artery to reactive hyperemia measured by flow mediated dilation before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Posted | Mean | 95% Confidence Interval | percentage of dilation | Baseline, 6 months post-intervention |
|
|
|
|
| Secondary | Change in Arterial Stiffness | Pulse wave velocity (m/s) of the descending aorta measured using the Complior system before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Posted | Mean | 95% Confidence Interval | m/s | Baseline, 6 months post-intervention |
|
|
|
|
| Secondary | Change in Lipid Profile - HDL (High-Density Lipoprotein), LDL (Low-Density Lipoprotein), and Triglycerides | Lipids (HDL, LDL, and Triglycerides) from fasting venous blood draw measured before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention). | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline, 6 months post-intervention |
|
|
|
|
| Secondary | Change in Nighttime Sympathetic Nervous System Activity | Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) before and after CBT-I. Adjusted via creatinine normalization by dividing by the urine creatinine concentration. | Posted | Mean | 95% Confidence Interval | micrograms/mg creatinine | Pre-CBT-I Baseline (6 weeks) to post-CBT-I (12 weeks) |
|
|
|
|
| Secondary | Change in Sleep Fragmentation During the Nighttime Sleep Period | Sleep Fragmentation Index (SFI) measured by actigraphy before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 weeks post-intervention). The SFI measures how often sleep is interrupted by brief awakenings or shifts between sleep stages, calculated by dividing the number of these transitions by total sleep time | Posted | Mean | 95% Confidence Interval | transitions/hour | Baseline, 6 weeks post-intervention |
|
|
|
|
| Secondary | Change in Subjective Sleep Quality | Subjective Sleep Quality measured by Pittsburgh Sleep Quality Index (PSQI) before and after CBT-I. The PSQI is a widely used, self-report questionnaire that assesses sleep quality and disturbances over a one-month period, identifying factors like sleep latency (time to fall asleep), duration, disturbances, medication use, and daytime dysfunction, yielding a global score (0-21) where higher scores indicate poorer sleep. | Posted | Mean | 95% Confidence Interval | score on a scale | Pre-CBT-I baseline (6 week) to post-CBT-I (12 weeks) |
|
|
|
| Secondary | Change in Clinic Blood Pressure | Average office seated blood pressure taken by automated clinic blood pressure monitor after 5 minutes rest and based on the average of 3 readings taken at one minute intervals (mm Hg) | Posted | Mean | 95% Confidence Interval | mmHg | Baseline to 6 months post-intervention |
|
|
|
|
| Other Pre-specified | Change in Cardiac Function | Cardiac left ventricular strain (%) before and after CBT-I | Not Posted | 6 week, 6 months post intervention | Participants |
| Other Pre-specified | Change in Cardiac Structure | Cardiac left ventricular mass (g m^-2.7) before and after CBT-I | Not Posted | 6 week, 6 months post intervention | Participants |
| 0 |
| 149 |
| 0 |
| 149 |
| 0 |
| 149 |
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| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| 0.025 |
| Other |
| 0.018 |
| Other |
| Title | Measurements |
|---|---|
|
| 0.858 |
| Other |
| Triglycerides | Mixed Models Analysis | 0.857 | Other |
| Other |
| 0.025 |
| Other |