Trial Outcomes & Findings for Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension (NCT NCT04009447)

NCT ID: NCT04009447

Last Updated: 2026-02-23

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

149 participants

Primary outcome timeframe

Baseline, 6 months post-intervention

Results posted on

2026-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	149
Overall Study COMPLETED	127
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Behavioral Therapy for Insomnia n=127 Participants 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
Age, Continuous	47.8 years STANDARD_DEVIATION 8.4 • n=58 Participants
Sex: Female, Male Female	67 Participants n=58 Participants
Sex: Female, Male Male	60 Participants n=58 Participants
Race/Ethnicity, Customized Race · White	97 Participants n=58 Participants
Race/Ethnicity, Customized Race · Black	23 Participants n=58 Participants
Race/Ethnicity, Customized Race · Asian	5 Participants n=58 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=58 Participants
Region of Enrollment United States	127 Participants n=58 Participants
Body Mass Index (BMI)	27.5 kg/m^2 STANDARD_DEVIATION 4.7 • n=58 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months post-intervention

Population: Participants who completed the study.

Average nighttime blood pressure measured before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention).

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy for Insomnia n=127 Participants 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
Change in Blood Pressure During the Nighttime Sleep Period Systolic blood pressure (SBP)	-2.48 mmHg Interval -4.2 to -0.7
Change in Blood Pressure During the Nighttime Sleep Period Diastolic blood pressure (DBP)	-1.90 mmHg Interval -3.1 to -0.7

PRIMARY outcome

Timeframe: Baseline, 6 months post-intervention

Population: Participants who completed the study.

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).

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy for Insomnia n=127 Participants 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
Change in Sleep During the Nighttime Sleep Period as Measured by Sleep Diary	6.9 percentage of time asleep Interval 6.2 to 7.6

PRIMARY outcome

Timeframe: Baseline, 6 months post-intervention

Population: Participants who completed the study.

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).

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy for Insomnia n=127 Participants 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
Change in Sleep During the Nighttime Sleep Period as Measured by Actigraphy	1.4 percentage of time asleep Interval -0.6 to 3.5

PRIMARY outcome

Timeframe: Baseline, 6 months post-intervention

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.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy for Insomnia n=127 Participants 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
Changes in Insomnia Severity as Measured by the Insomnia Severity Index (ISI)	-7.9 score on a scale Interval -8.8 to -7.0

SECONDARY outcome

Timeframe: Baseline, 6 months post-intervention

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).

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy for Insomnia n=127 Participants 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
Change in Awake Blood Pressure Systolic blood pressure (SBP)	-1.38 mmHg Interval -2.6 to -0.2
Change in Awake Blood Pressure Diastolic blood pressure (DBP)	-1.96 mmHg Interval -3.2 to -0.7

SECONDARY outcome

Timeframe: Baseline, 6 months post-intervention

Average percent change in blood pressure before CBT-I (Cognitive Behavioral Therapy for Insomnia) (baseline) and after CBT-I (6 months post-intervention).

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy for Insomnia n=127 Participants 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
Change in Nighttime Blood Pressure Dip Percentage Systolic blood pressure (SBP)	0.90 percentage points Interval 0.1 to 1.7
Change in Nighttime Blood Pressure Dip Percentage Diastolic blood pressure (DBP)	1.80 percentage points Interval 0.3 to 3.2

SECONDARY outcome

Timeframe: Baseline, 6 months post-intervention

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).

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy for Insomnia n=127 Participants 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
Change in Vascular Endothelial Function	1.41 percentage of dilation Interval 0.57 to 2.26

SECONDARY outcome

Timeframe: Baseline, 6 months post-intervention

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).

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy for Insomnia n=127 Participants 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
Change in Arterial Stiffness	0.09 m/s Interval -0.28 to 0.1

SECONDARY outcome

Timeframe: Baseline, 6 months post-intervention

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).

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy for Insomnia n=127 Participants 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
Change in Lipid Profile - HDL (High-Density Lipoprotein), LDL (Low-Density Lipoprotein), and Triglycerides HDL	-1.82 mg/dL Interval -3.4 to -0.24
Change in Lipid Profile - HDL (High-Density Lipoprotein), LDL (Low-Density Lipoprotein), and Triglycerides LDL	0.27 mg/dL Interval -2.73 to 3.28
Change in Lipid Profile - HDL (High-Density Lipoprotein), LDL (Low-Density Lipoprotein), and Triglycerides Triglycerides	0.68 mg/dL Interval -6.8 to 8.17

SECONDARY outcome

Timeframe: Pre-CBT-I Baseline (6 weeks) to post-CBT-I (12 weeks)

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.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy for Insomnia n=127 Participants 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
Change in Nighttime Sympathetic Nervous System Activity Nighttime Epinephrine	0.01 micrograms/mg creatinine Interval -0.04 to 0.06
Change in Nighttime Sympathetic Nervous System Activity Nighttime Norepinephrine	0.06 micrograms/mg creatinine Interval -0.42 to 0.55

SECONDARY outcome

Timeframe: Baseline, 6 weeks post-intervention

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

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy for Insomnia n=127 Participants 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
Change in Sleep Fragmentation During the Nighttime Sleep Period	-1.60 transitions/hour Interval -5.5 to 2.3

SECONDARY outcome

Timeframe: Pre-CBT-I baseline (6 week) to post-CBT-I (12 weeks)

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.

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy for Insomnia n=127 Participants 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
Change in Subjective Sleep Quality	-3.53 score on a scale Interval -4.08 to -2.99

SECONDARY outcome

Timeframe: Baseline to 6 months post-intervention

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)

Outcome measures

Outcome measures
Measure	Cognitive Behavioral Therapy for Insomnia n=127 Participants 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
Change in Clinic Blood Pressure Systolic blood pressure (SBP)	-1.75 mmHg Interval -3.6 to 0.1
Change in Clinic Blood Pressure Diastolic blood pressure (DBP)	-0.09 mmHg Interval -1.3 to 1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 week, 6 months post intervention

Cardiac left ventricular strain (%) before and after CBT-I

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 week, 6 months post intervention

Cardiac left ventricular mass (g m\^-2.7) before and after CBT-I

Outcome measures

Outcome data not reported

Adverse Events

Cognitive Behavioral Therapy for Insomnia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew Sherwood, Ph.D.

Duke University

Phone: 919-684-8835

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place