10 Participants Needed

Sleep Promotion App for High Blood Pressure

GV
JM
AS
Overseen ByAbby Salem
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to help kids with high blood pressure (hypertension) get more sleep. The goal is to determine if increased sleep can lower blood pressure in these children. Participants will receive sleep guidance, encouragement, and feedback through the app, known as the Mobile Health Sleep Extension Approach. Ideal candidates are kids who sleep less than 7.5 hours on school nights and have recently been diagnosed with high blood pressure. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance sleep and health outcomes for children with hypertension.

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 prior data suggests that this mobile health sleep extension approach is safe for increasing sleep duration and reducing blood pressure in pediatric nephrology patients?

Research has shown that mobile health (mHealth) programs, like the one in this trial, are generally safe for users. One study found that an mHealth program effectively managed blood pressure without causing significant side effects. It focused on people with high blood pressure and reported that the program was well-tolerated. Another study demonstrated that using a wearable device with a smartphone app helped people with high blood pressure adhere to their treatment plans, again without major safety concerns. These findings suggest that using a mobile app to improve sleep and lower blood pressure is likely safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the Sleep Promotion App for high blood pressure because it offers a novel, non-drug approach to managing hypertension. Unlike standard treatments that typically involve medication to lower blood pressure, this app focuses on improving sleep quality through a Mobile Health Sleep Extension Approach. The app provides personalized sleep goals, guidance messaging, and supportive feedback, which can empower users to make lifestyle changes. This method not only aims to enhance sleep but also leverages behavioral incentives, making it a unique tool that could complement or reduce reliance on traditional medications.

What evidence suggests that this mobile health sleep extension approach is effective for high blood pressure?

Research has shown that mobile health apps can help people manage their sleep and health effectively. In this trial, participants will use the Mobile Health Sleep Extension Approach, which includes a sleep goal, sleep guidance messaging, loss-framed incentive, and supportive feedback. Studies have found that these types of apps can help people adhere to treatments for high blood pressure, giving them more control over their health. One study discovered that using a mobile health app helped patients stay committed to managing their high blood pressure. Although a smartphone coaching app did not lower blood pressure more than just tracking it, other research showed that people were more likely to follow their treatment plans. Overall, mobile health apps appear promising in helping users improve sleep and manage blood pressure better.23678

Who Is on the Research Team?

JM

Jonathan Mitchell, PhD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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.
See 3 more

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
749
Recruited
11,400,000+

Published Research Related to This Trial

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.
Development of DASH Mobile: a mHealth lifestyle change intervention for the management of hypertension.Mann, DM., Kudesia, V., Reddy, S., et al.[2013]
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.
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]
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.
The Potential of mHealth Applications in Improving Resistant Hypertension Self-Assessment, Treatment and Control.Santo, K., Redfern, J.[2020]

Citations

A scoping review of mobile apps for sleep managementExisting studies have proved the initial validation and efficiency of delivering sleep treatment by mobile apps; however, more research is ...
Effect of Home Blood Pressure Monitoring via a ...Participants randomized to a smartphone coaching app did not have lower blood pressure at 6 months compared with those receiving a blood pressure tracking app.
Effectiveness of an mHealth Program on Reducing Blood ...Objective: This study aims to assess the prevalence of prehypertension among young adults and evaluate the effectiveness of an mHealth ...
Using a mobile health app to improve patients' adherence to ...This study suggests that using an mHealth app can empower patients to manage their own health and increase adherence to hypertension treatment.
Effectiveness of a mHealth intervention on hypertension ...After 12 weeks of follow-up, the mean (SD) hypertension compliance increased by 7.35 (7.31) in the intervention group and by 3.01 (4.92) in the ...
A Mobile Health-Based Disease Management Program ...This study investigated the effects of a mobile health (mHealth)-based disease management program on blood pressure and the safety of this program in people ...
a randomized controlled study of a behavioral sleep extension ...The objective of this study is to test the effects of a behavioral sleep extension intervention on sleep duration, blood pressure, and other measures of ...
The Effect of an AI-Based, Autonomous, Digital Health ...This study assesses the effectiveness of a fully digital, autonomous, and artificial intelligence (AI)–based lifestyle coaching program on achieving BP control ...
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