Elevated Blood PressureSTITCHNCT04766424
Sleep Technology Intervention to Target Cardiometabolic Health
A study testing Sleep extension intervention and Health education in people with Elevated Blood Pressure and Habitual Sleep Duration of Less Than or Equal to 7 Hours, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Blood Pressure, Habitual Sleep Duration of Less Than or Equal to 7 Hours
- What is being tested?
- Sleep extension intervention and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 14 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Behavioral Sleep Extension Intervention on Cardiometabolic Risk Factors Among Patients With Elevated BP/Hypertension
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.
Read the 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.
- Being tested
- Sleep extension intervention, Health education
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep extension interventionBehavioural
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.
Health educationBehavioural
Participants will receive 8 weekly health education newsletters delivered via email.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral sleep extension group | Experimental | 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. Receives: Behavioral: Sleep extension intervention |
| Health education | Other | 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. Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep duration
Sleep duration will be measured using wrist actigraphy for 7 days
Measured: 8 weeks
Secondary outcomes (3)
24 hour ambulatory blood pressure
Ambulatory blood pressure glycemic control, lipids).
Measured: 8 weeks
24 hour ambulatory blood pressure
Ambulatory blood pressure glycemic control, lipids).
Measured: 12 months
Sleep duration
Sleep duration will be measured using wrist actigraphy for 7 days
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start30 Mar 2021
- Primary completion14 Jun 2024
- Study completion14 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elevated Blood PressureStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Kelly Glazer Baron, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766424
- Sponsor's protocol ID
- 10055552
- Other IDs
- 1R01NR018891-01A1
- Acronym
- STITCH
- Status last verified
- Jun 2024
- First submitted
- 13 Feb 2021
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon request to the investigators at the end of the study.
Publications
Baron KG, Duffecy J, Simonsen S, Bress A, Conroy MB, Greene T, Allen C, Vallejo S. Sleep Technology Intervention to Target Cardiometabolic Health (STITCH): a randomized controlled study of a behavioral sleep extension intervention compared to an education control to improve sleep duration, blood pressure, and cardiometabolic health among adults with elevated blood pressure/hypertension. Trials. 2023 Oct 10;24(1):658. doi: 10.1186/s13063-023-07658-6.
PubMed 37817267
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Behavioral Sleep Extension Intervention on Cardiometabolic Risk Factors Among Patients With Elevated BP/Hypertension
- ClinicalTrials.gov ID
- NCT04766424
- Acronym / sponsor ID
- STITCH / 10055552
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, National Institute of Nursing Research (NINR)
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2025 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral sleep extension group | Experimental | Behavioral: Sleep extension interventionParticipants 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. |
| Health education | Other | Behavioral: Health educationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep extension interventionParticipants 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. | Behavioural | Behavioral sleep extension group |
| Health educationParticipants will receive 8 weekly health education newsletters delivered via email. | Behavioural | Health education |
Primary outcome
Sleep duration
Time frame: 8 weeks
Sleep duration will be measured using wrist actigraphy for 7 days
3 secondary outcomes
24 hour ambulatory blood pressure
Time frame: 8 weeks
24 hour ambulatory blood pressure
Time frame: 12 months
Sleep duration
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Derived from this study: PubMed 37817267Baron KG, Duffecy J, Simonsen S, Bress A, Conroy MB, Greene T, Allen C, Vallejo S. Sleep Technology Intervention to Target Cardiometabolic Health (STITCH): a randomized controlled study of a behavioral sleep extension intervention compared to an education control to improve sleep duration, blood pressure, and cardiometabolic health among adults with elevated blood pressure/hypertension. Trials. 2023 Oct 10;24(1):658. doi: 10.1186/s13063-023-07658-6.
- Individual participant dataSharing planned: Yes. Data will be made available upon request to the investigators at the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep extension intervention and Health education in people with Elevated Blood Pressure and Habitual Sleep Duration of Less Than or Equal to 7 Hours, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep duration (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.