Sleep Promotion App for High Blood Pressure

Overseen By Jonathan Mitchell

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Must not be taking: Anti-hypertensives, Glucocorticoids, Stimulants

Disqualifiers: Sleep disorders, Cardiac disease, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Determine the effectiveness and feasibility of a mobile health sleep extension approach in the pediatric nephrology setting, to increase sleep duration and reduce systolic and diastolic blood pressure.

Will I have to stop taking my current medications?

The trial requires participants to stop taking over-the-counter sleep aids during the study. If you are taking other medications, especially those affecting blood pressure, you may not be eligible to participate.

What data supports the effectiveness of the Sleep Promotion App for High Blood Pressure treatment?

Research shows that increasing sleep duration can help lower blood pressure in people with prehypertension or stage 1 hypertension. A study found that participants who extended their sleep had a significant decrease in blood pressure compared to those who did not change their sleep habits. ^{1 2 3 4 5}

Is the Sleep Promotion App safe for humans?

The study on the technology-assisted sleep extension intervention for people with high blood pressure did not report any safety concerns, suggesting it is generally safe for humans. ^{1 2 5 6 7}

How is the Sleep Promotion App for High Blood Pressure different from other treatments?

The Sleep Promotion App for High Blood Pressure is unique because it uses a mobile health approach to extend sleep, which is a novel method for managing high blood pressure. Unlike traditional treatments that focus on medication or diet, this app leverages technology to promote better sleep habits, potentially improving blood pressure control through enhanced rest. ^{8 9 10 11 12}

Research Team

Jonathan Mitchell, PhD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for children with high blood pressure potentially linked to not getting enough sleep. Participants should be currently receiving care in a pediatric nephrology setting. The specific inclusion and exclusion criteria are not provided, but typically would detail age range, health status, and other relevant factors.

Inclusion Criteria

Speak, read and write in English

Parent reported sleep duration on school nights less than or equal to 7.5 hours

I have been recently diagnosed with high blood pressure.

Exclusion Criteria

I have a diagnosed sleep disorder or use prescribed sleep aids regularly.

I have a chronic condition that requires regular medication and may affect my blood pressure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Run-in

Baseline sleep patterns are captured using a sleep tracker and home sleep polysomnography test

2 weeks

Home-based monitoring

Intervention

Participants receive a mobile health sleep extension intervention with sleep goals, guidance messaging, and financial incentives

7 weeks

Weekly virtual feedback

Follow-up

Participants are monitored for changes in sleep duration and blood pressure

2 weeks

Home-based monitoring

Treatment Details

Interventions

• Mobile Health Sleep Extension Approach

Trial Overview The study is testing whether using mobile health technology to encourage more sleep can help kids sleep longer and lower their blood pressure. It's likely that the approach involves an app or device designed to promote better sleep habits.

Participant Groups

Group I: Arm 1 Experimental Treatment 1 Intervention

Sleep goal, Sleep guidance messaging, Loss-framed incentive, Supportive feedback.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Findings from Research

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 DASH Mobile system is designed to help hypertensive patients adopt the DASH diet, which emphasizes fruits, vegetables, low-fat dairy, and lean protein, while also promoting physical activity and reducing sodium intake.

This mobile health (mHealth) app aims to make it easier for users to track their diet and health metrics, potentially overcoming the challenges of traditional in-person interventions and improving patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of DASH Mobile: a mHealth lifestyle change intervention for the management of hypertension. Mann, DM., Kudesia, V., Reddy, S., et al.[2013]

Smartphone applications can significantly enhance the management of hypertension by improving medication adherence, blood pressure control, and promoting lifestyle changes, especially among younger users.

While technology interventions show promise in reducing physical inactivity and obesity, further research is needed to identify the most effective components of these interventions and to make them more accessible for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mobile applications and management of hypertension: possibilities, problems and perspectives]. Becker, S., Mitchell, A., Königsmann, T., et al.[2021]

Mobile health (mHealth) apps can effectively assist in the self-assessment and management of resistant hypertension, providing tools for regular blood pressure monitoring and communication between patients and healthcare professionals.

While mHealth apps show promise in improving hypertension control, their accuracy in measuring blood pressure can vary, and more extensive research is needed to confirm their long-term effectiveness and scalability in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential of mHealth Applications in Improving Resistant Hypertension Self-Assessment, Treatment and Control. Santo, K., Redfern, J.[2020]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Different effects of ambulatory blood pressure monitoring on subjective and objective sleep quality. [2015]

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

Total sleep time and other sleep characteristics measured by actigraphy do not predict incident hypertension in a cohort of community-dwelling older men. [2022]

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

Increasing sleep duration to lower beat-to-beat blood pressure: a pilot study. [2021]

5. Brazil pubmed.ncbi.nlm.nih.gov

Influence of quality of sleep on the nocturnal decline in blood pressure during ambulatory blood pressure monitoring. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Does non-invasive ambulatory blood pressure monitoring disturb sleep? [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effects of ambulatory blood pressure monitoring on sleep in healthy, normotensive men and women. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Development of DASH Mobile: a mHealth lifestyle change intervention for the management of hypertension. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

[Mobile applications and management of hypertension: possibilities, problems and perspectives]. [2021]

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

Meditation smartphone application effects on prehypertensive adults' blood pressure: Dose-response feasibility trial. [2019]

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

Development and Initial Use of an Evidence-Based Home Blood Pressure Monitoring mHealth Platform. [2023]

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

The Potential of mHealth Applications in Improving Resistant Hypertension Self-Assessment, Treatment and Control. [2020]