Back to resultsSleep Technology Intervention to Target Cardiometabolic Health (STITCH)
Primary Purpose
Elevated Blood Pressure, Habitual Sleep Duration of Less Than or Equal to 7 Hours
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep extension intervention
Health education
Sponsored by
About this trial
This is an interventional treatment trial for Elevated Blood Pressure
Eligibility Criteria
Inclusion Criteria:
- Age 18-65
- 24h ABP readings indicating elevated blood pressure (BP) or hypertension (24h average systolic (SBP) of 115-145 mmHg or diastolic (DBP) of 75-90 mmHg). Patients taking antihypertensive medications will be permitted if stable dose for >8 weeks
- Time in bed <8 hours and habitual sleep duration <7 hours via actigraphy;
- Smartphone user
- Able to read/write in English.
Exclusion Criteria:
- High risk or presence of moderate to severe comorbid sleep disorders (i.e., obstructive sleep apnea AHI 15 or greater, restless legs syndrome, or insomnia) as assessed by the questionnaires and overnight obstructive sleep apnea at the baseline/screening
- Resistant hypertension, defined as >4 antihypertensive medications or taking medications and standardized in lab BP >130 mmHg SBP or 80 mmHg DBP at screening History of cognitive or neurological disorders (e.g. dementia, Parkinson's, Multiple Sclerosis)
- BMI>50 kg/m2 or arm circumference greater than extra large cuff
- Presence of major psychiatric disorders (e.g. schizophrenia, bipolar disorder)
- alcohol abuse on the Audit-C (score >4 for men, >3 for women)
- drug use on the NIDA-Modified ASSIST (score >3),90
- moderate to severe depressive symptoms (PHQ-8 >10)
- Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis)
- Overnight work more than 1x per month
- Use of hypnotic or stimulant medications
- Situations that would significantly impact the ability to extend sleep, including overnight caregiving responsibility for children under the age 1, elderly or disabled adults >1x per week
- Inability to read or write in English
- Pregnancy/desire to become pregnant during the study period.
Sites / Locations
- University of UtahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Behavioral sleep extension group
Health education
Arm Description
Participants in the sleep extension group will receive a fitbit, weekly coaching calls and educational materials for 8 weeks. In months 3-6, they will receive educational materials and an email from the coach each month.
Participants in the health education group will receive 8 weekly health education emails and telephone calls to confirm their receipt and clarify any concepts from the materials. In months 3-6, they will receive monthly health education materials.
Outcomes
Primary Outcome Measures
Sleep duration
Sleep duration will be measured using wrist actigraphy for 7 days
Secondary Outcome Measures
24 hour ambulatory blood pressure
Ambulatory blood pressure glycemic control, lipids).
24 hour ambulatory blood pressure
Ambulatory blood pressure glycemic control, lipids).
Sleep duration
Sleep duration will be measured using wrist actigraphy for 7 days
Full Information
NCT ID
NCT04766424
First Posted
February 13, 2021
Last Updated
May 8, 2023
Sponsor
University of Utah
Collaborators
University of Illinois at Chicago, National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT04766424
Brief Title
Sleep Technology Intervention to Target Cardiometabolic Health
Acronym
STITCH
Official Title
Effects of a Behavioral Sleep Extension Intervention on Cardiometabolic Risk Factors Among Patients With Elevated BP/Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
University of Illinois at Chicago, National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this study is to test the efficacy of a behavioral sleep extension intervention on sleep duration, cardio-metabolic disease risk factors, and health behaviors among adults with elevated blood pressure/hypertension and short sleep duration.
Detailed Description
Half of U.S. adults have at least one cardio-metabolic disease (CMD), including hypertension (HTN), heart disease, stroke, or diabetes. Even with advances in screening, education, and medication management, controlling these chronic diseases remains challenging. Despite the well-established negative effects of short sleep duration, surprisingly few studies have tested the benefits of sleep extension and even fewer studies evaluate the science of sleep extension interventions. Therefore, the goal of this study is to test the efficacy of a behavioral sleep extension intervention on sleep duration, CMD risk factors, and health behaviors among adults with elevated BP/HTN and short sleep duration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elevated Blood Pressure, Habitual Sleep Duration of Less Than or Equal to 7 Hours
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigators and outcomes assessors will not have access to the randomization table. Outcomes assessors will not be involved in the group assignments. Participants will be instructed to not tell outcomes assessors which group they are assigned to.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioral sleep extension group
Arm Type
Experimental
Arm Description
Participants in the sleep extension group will receive a fitbit, weekly coaching calls and educational materials for 8 weeks. In months 3-6, they will receive educational materials and an email from the coach each month.
Arm Title
Health education
Arm Type
Other
Arm Description
Participants in the health education group will receive 8 weekly health education emails and telephone calls to confirm their receipt and clarify any concepts from the materials. In months 3-6, they will receive monthly health education materials.
Intervention Type
Behavioral
Intervention Name(s)
Sleep extension intervention
Intervention Description
Participants will receive a fitbit and 8 weekly sleep-related educational materials via email and telephone coaching to review their sleep tracker data, set goals, trouble shoot any problems, and increase motivation.
Intervention Type
Behavioral
Intervention Name(s)
Health education
Intervention Description
Participants will receive 8 weekly health education newsletters delivered via email.
Primary Outcome Measure Information:
Title
Sleep duration
Description
Sleep duration will be measured using wrist actigraphy for 7 days
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
24 hour ambulatory blood pressure
Description
Ambulatory blood pressure glycemic control, lipids).
Time Frame
8 weeks
Title
24 hour ambulatory blood pressure
Description
Ambulatory blood pressure glycemic control, lipids).
Time Frame
12 months
Title
Sleep duration
Description
Sleep duration will be measured using wrist actigraphy for 7 days
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Diet
Description
24 hour diet recall
Time Frame
8 weeks
Title
Diet
Description
24 hour diet recall
Time Frame
12 months
Title
Physical activity
Description
Accelerometer measured activity over 7 days
Time Frame
8 weeks
Title
Physical activity
Description
Accelerometer measured activity over 7 days
Time Frame
12 months
Title
HbA1c
Description
Cardiometabolic marker
Time Frame
12 months
Title
C-reactive protein (CRP)
Description
Cardiometabolic marker
Time Frame
8 weeks
Title
C-reactive protein (CRP)
Description
Cardiometabolic marker
Time Frame
12 months
Title
IL-6
Description
Cardiometabolic marker
Time Frame
8 weeks
Title
IL-6
Description
Cardiometabolic marker
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-65
24h ABP readings indicating elevated blood pressure (BP) or hypertension (24h average systolic (SBP) of 115-145 mmHg or diastolic (DBP) of 75-90 mmHg). Patients taking antihypertensive medications will be permitted if stable dose for >8 weeks
Time in bed <8 hours and habitual sleep duration <7 hours via actigraphy;
Smartphone user
Able to read/write in English.
Exclusion Criteria:
High risk or presence of moderate to severe comorbid sleep disorders (i.e., obstructive sleep apnea AHI 15 or greater, restless legs syndrome, or insomnia) as assessed by the questionnaires and overnight obstructive sleep apnea at the baseline/screening
Resistant hypertension, defined as >4 antihypertensive medications or taking medications and standardized in lab BP >130 mmHg SBP or 80 mmHg DBP at screening History of cognitive or neurological disorders (e.g. dementia, Parkinson's, Multiple Sclerosis)
BMI>50 kg/m2 or arm circumference greater than extra large cuff
Presence of major psychiatric disorders (e.g. schizophrenia, bipolar disorder)
alcohol abuse on the Audit-C (score >4 for men, >3 for women)
drug use on the NIDA-Modified ASSIST (score >3),90
moderate to severe depressive symptoms (PHQ-8 >10)
Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis)
Overnight work more than 1x per month
Use of hypnotic or stimulant medications
Situations that would significantly impact the ability to extend sleep, including overnight caregiving responsibility for children under the age 1, elderly or disabled adults >1x per week
Inability to read or write in English
Pregnancy/desire to become pregnant during the study period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Baron, Ph.D.
Phone
8015857588
Email
kelly.baron@utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Vallejo
Phone
8015851123
Email
sofia.vallejo@hsc.utah.edu
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Vallejo, PhD
Email
sofia.vallejo@utah.edu
First Name & Middle Initial & Last Name & Degree
Kelly Baron, PhD
Phone
801-585-7588
Email
kelly.baron@utah.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available upon request to the investigators at the end of the study.
IPD Sharing Time Frame
Within 1 year upon completion fo the study
IPD Sharing Access Criteria
Written request to the PI
Learn more about this trial
Sleep Technology Intervention to Target Cardiometabolic Health
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