Sleep Health Intervention for High Blood Pressure

Overseen By Nour Makarem, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Cardiovascular disease, Cancer, Severe psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

250 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Sleep Health Intervention for High Blood Pressure treatment?

Research shows that improving sleep quality through interventions like sleep-hygiene education and cognitive behavioral therapy can help lower blood pressure, which is a key factor in managing high blood pressure. ^{1 2 3 4 5}

Is the Sleep Health Intervention for High Blood Pressure safe for humans?

The Sleep Health Intervention, which includes sleep-hygiene education and cognitive behavioral therapy, has been evaluated in studies and is generally considered safe for humans. These interventions focus on improving sleep habits and have not been associated with any significant safety concerns. ^{2 3 6 7 8}

How is the Multidimensional Sleep Health Promotion Intervention treatment different from other treatments for high blood pressure?

The Multidimensional Sleep Health Promotion Intervention is unique because it focuses on improving sleep health through education and behavioral changes, rather than using medication. This approach addresses various sleep factors like sleep duration and quality, which are linked to high blood pressure, making it different from standard treatments that typically involve drugs. ^{2 3 9 10 11}

What is the purpose of this trial?

The purpose of this randomized controlled trial is to evaluate the impact of a multidimensional sleep health promotion intervention on blood pressure, glycemic control indicators, anthropometric markers of adiposity, and lifestyle factors in Hispanic/Latina/o/x adults. Participants will be randomized into an intervention or a control group. The control arm will receive standard Life's Essential 8 cardiovascular health educational materials. The intervention arm will additionally receive a multi-component intervention aimed at improving sleep health based on evidence-based sleep hygiene education and established behavior change techniques that include personalized sleep health feedback, goal setting and establishing a sleep health plan, coaching, self-monitoring, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation determinants, processes, and outcomes, ensuring the successful completion and future expansion of this intervention.

Research Team

Nour Makarem, PhD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for Hispanic/Latina/o/x adults with high blood pressure. Participants should be interested in improving their sleep health to potentially better their heart health and lifestyle factors. Details on specific inclusion or exclusion criteria are not provided, but typically these would outline who can safely participate.

Inclusion Criteria

Systolic blood pressure greater than or equal to 120 mmHg

Presence of sub-optimal sleep health

I am between 30 and 65 years old.

Exclusion Criteria

Presence of severe psychiatric disorders

I am unable to understand or complete the study tasks.

Presence of optimal sleep health

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multidimensional sleep health promotion intervention, including virtual sleep health education, personalized feedback, and behavioral coaching

24 weeks

Regular virtual sessions

Follow-up

Participants are monitored for changes in cardiometabolic health indicators and sleep health

4 weeks

Treatment Details

Interventions

• Multidimensional Sleep Health Promotion Intervention

Trial Overview The study tests a special program designed to help people sleep better and see if it improves blood pressure and other health markers related to diabetes and weight. Half the participants will get this new sleep improvement program, while the other half will receive standard heart health information.

Participant Groups

Group I: Multidimensional Sleep Health Promotion Intervention Experimental Treatment 1 Intervention

Participants randomized to the intervention arm will receive: 1. A multi-component multidimensional sleep health promotion intervention that includes virtual sleep health and sleep hygiene education, personalized feedback and establishment of a sleep health plan, behavioral coaching, self-monitoring, supportive accountability, and addressing light and noise in the sleep environment. 2. Cardiovascular health education materials based on the American Heart Association's Life's Essential 8 framework.

Group II: Standard of care Active Control 1 Intervention

Participants randomized to the control arm will receive standard American Heart Association Life's Essential 8 cardiovascular health education materials.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

Sleep deficiency is a widespread issue among hospitalized patients, influenced by factors like existing health conditions and the hospital environment, which can negatively affect multiple organ systems.

To improve patient outcomes, it's crucial to enhance objective sleep measurement methods in hospitals and standardize study protocols to better assess the effectiveness of sleep promotion strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding Insult to Injury: Sleep Deficiency in Hospitalized Patients. Mansour, W., Knauert, M.[2023]

A web-delivered sleep intervention significantly improved sleep quality and psychosocial health in 134 participants with mild sleep impairment, but it did not lead to significant reductions in blood pressure over 8 weeks.

The intervention group showed notable improvements in various sleep quality measures and mental health indicators, but the change in 24-hour ambulatory systolic blood pressure was similar to the control group, indicating that while sleep quality improved, it did not translate to immediate cardiovascular benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep to Lower Elevated Blood Pressure: A Randomized Controlled Trial (SLEPT). McGrath, ER., Espie, CA., Power, A., et al.[2018]

A 6-week technology-assisted sleep extension intervention significantly improved total sleep time and reduced both systolic and diastolic blood pressure in adults with prehypertension or stage 1 hypertension, indicating its potential efficacy in managing these conditions.

Participants found the intervention enjoyable and engaged well, completing 90% of coaching sessions, which suggests that such technology-assisted approaches could be feasible and well-received for improving sleep and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology Assisted Behavior Intervention to Extend Sleep Among Adults With Short Sleep Duration and Prehypertension/Stage 1 Hypertension: A Randomized Pilot Feasibility Study. Baron, KG., Duffecy, J., Richardson, D., et al.[2023]

The SLeep Education for Elders Program (SLEEP) showed sustained improvements in sleep quality, duration, insomnia symptoms, and sleep hygiene behaviors six months after the program ended, based on surveys from 19 participants.

These findings indicate that community-delivered sleep education interventions can effectively address uncomplicated sleep issues and provide lasting benefits beyond the program duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SLeep Education for Everyone Program (SLEEP) Results in Sustained Improvements in Sleep Outcomes at Six Months. Haggerty, D., Contreras, DA., Carter, A., et al.[2023]

In a 3-month pilot trial involving 29 older adults, an intervention using visualized sleep report feedback and health guidance significantly improved sleep latency, total sleep time, and sleep efficiency, indicating potential benefits for sleep quality.

The intervention led to a notable increase in total sleep time and improved sleep efficiency by the end of the study, suggesting that this approach could be effective in enhancing sleep among older adults, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of sleep report feedback using information and communication technology combined with health guidance on improving sleep indicators in community-dwelling older people: a pilot trial. Mo, W., Yamakawa, M., Takahashi, S., et al.[2023]

Involving stakeholders such as young adults, parents, and healthcare providers in the development of sleep promotion programs for adolescents is essential for creating effective and acceptable interventions, as highlighted by feedback from 9 focus groups with 49 participants.

Strategies to improve adolescent sleep should focus on enhancing internal motivation, personalizing content, and encouraging parents to model good sleep behaviors, which can help sustain behavior change and make programs more feasible and scalable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing adolescent sleep interventions with stakeholder input. Levenson, JC., Ford, HA., Reyes, ZMD., et al.[2022]

Sleep health disparities (SHDs) are prevalent among disadvantaged populations in the U.S. and are linked to various negative health outcomes and behaviors, indicating a significant public health concern.

To effectively address SHDs, researchers recommend integrating sleep health with existing health disparity frameworks and developing comprehensive interventions that consider multiple factors influencing sleep and health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A workshop report on the causes and consequences of sleep health disparities. Jackson, CL., Walker, JR., Brown, MK., et al.[2021]

A sleep health program consisting of four weekly group sessions significantly improved both objective and self-reported sleep parameters among 63 members of the German Armed Forces, demonstrating its effectiveness as a workplace health promotion tool.

Participants in the treatment group experienced notable improvements in sleep quality metrics, including sleep efficiency and latency to persistent sleep, with moderate effects on daytime sleepiness, indicating the program's potential as a preventive measure for sleep issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Workplace-Based Sleep Health Program on Sleep in Members of the German Armed Forces. Sauter, C., Kowalski, JT., Stein, M., et al.[2020]

In a study of 11,561 Chinese students aged 9-18, those who slept 8-9 hours had a significantly lower risk of high blood pressure (HBP) compared to those sleeping more than 10 hours, indicating that optimal sleep duration is crucial for cardiovascular health in children.

Sleep consistency, particularly bedtime regularity, was linked to HBP, with irregular bedtimes increasing the risk, while midday napping did not show a significant association with HBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between sleep characteristics and risk for high blood pressure among students aged 9-18: A cross-sectional study in China. Cui, L., Li, J., Lou, X., et al.[2023]

Short sleep duration (6-7 hours) and long sleep duration (over 8 hours) are both associated with an increased prevalence of hypertension, particularly in individuals under 45 and over 45 years old, respectively.

Habitual daytime napping appears to have a protective effect against hypertension, especially in individuals over 45 years old, and may reduce hypertension risk in those who sleep 7-8 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of long-term sleep habits and hypertension: a cross-sectional study in Chinese adults. Zhao, H., Gui, W., Huang, H., et al.[2022]

In a study of 12,166 adults aged 30-79, poor sleep patterns, including short sleep duration, trouble sleeping, and diagnosed sleep disorders, were significantly associated with an increased risk of hypertension, with odds ratios indicating a strong correlation.

Specifically, individuals with poor sleep patterns had nearly double the odds (OR = 1.90) of developing hypertension compared to those with healthier sleep patterns, highlighting the importance of good sleep for cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between Sleep and Hypertension: Findings from the NHANES (2007-2014). Li, C., Shang, S.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adding Insult to Injury: Sleep Deficiency in Hospitalized Patients. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Sleep to Lower Elevated Blood Pressure: A Randomized Controlled Trial (SLEPT). [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Technology Assisted Behavior Intervention to Extend Sleep Among Adults With Short Sleep Duration and Prehypertension/Stage 1 Hypertension: A Randomized Pilot Feasibility Study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

SLeep Education for Everyone Program (SLEEP) Results in Sustained Improvements in Sleep Outcomes at Six Months. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effect of sleep report feedback using information and communication technology combined with health guidance on improving sleep indicators in community-dwelling older people: a pilot trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Designing adolescent sleep interventions with stakeholder input. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A workshop report on the causes and consequences of sleep health disparities. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of a Workplace-Based Sleep Health Program on Sleep in Members of the German Armed Forces. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Associations between sleep characteristics and risk for high blood pressure among students aged 9-18: A cross-sectional study in China. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Association of long-term sleep habits and hypertension: a cross-sectional study in Chinese adults. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Relationship between Sleep and Hypertension: Findings from the NHANES (2007-2014). [2021]