Habit-Based Sleep Intervention with Texting for Circadian Dysregulation

Overseen By Sondra Tiab, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Berkeley

Must be taking: Sleep medications

Disqualifiers: Substance abuse, Mental illness, Sleep apnea, others

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

Compensation: Varies

Number of Visits: 9

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people with irregular sleep patterns improve their sleep habits. It tests a combination of habit-based sleep health sessions (Habit-based Sleep Health Intervention) with or without additional support through text messages (Text messaging intervention). Suitable participants have sleep schedules that frequently change by two hours or more and feel at risk in areas like emotions, behavior, or social interactions. The goal is to determine if the added text messages make it easier to maintain better sleep habits. As an unphased trial, this study offers participants the chance to contribute to innovative sleep health research and potentially enhance their own sleep habits.

Will I have to stop taking my current medications?

If you are taking medication for sleep, you can continue as long as the dose and frequency have been stable for at least 4 weeks. The trial does not specify about other medications.

What prior data suggests that this sleep intervention is safe?

Research has shown that habit-based sleep health programs are generally safe. Previous studies have used habit-building techniques to improve sleep, and participants have managed these programs well, with no major safety issues reported.

Regarding the text messaging component, studies have examined the use of text messages to enhance sleep. These have proven safe and effective in helping people develop better sleep habits. Participants in these studies did not report significant side effects from receiving text messages as part of their program.

Both the habit-based program and the text message component appear safe based on past research. Participants in similar studies have not experienced serious negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Habit-Based Sleep Intervention for circadian dysregulation because it focuses on changing sleep habits with personalized support. Unlike standard treatments that often involve medication, this approach uses tailored sleep health sessions combined with supportive text messages to reinforce positive behaviors. By targeting habits directly, this intervention aims to naturally adjust the body's internal clock, potentially offering a drug-free alternative to improve sleep patterns. The text message component provides ongoing motivation and guidance, which could enhance adherence and effectiveness compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for circadian dysregulation?

Research has shown that consistent sleep habits can improve sleep health. In this trial, one group of participants will receive a Habit-based Sleep Health Intervention (HABITs), which includes structured sessions to develop these habits. Another group will combine this intervention with supportive text messages. Studies have found that adding text messages enhances effectiveness by reminding people to adhere to their new routines. These reminders have been linked to reduced sleepiness and fatigue. Evidence suggests that mobile phone reminders can help reduce sleep problems by keeping individuals focused on their sleep goals. Overall, combining habit-building strategies with supportive text messages appears promising for improving sleep quality and establishing better sleep patterns. ^{4 6 7 8 9}

Who Is on the Research Team?

Allison G Harvey, PhD

Principal Investigator

University of California, Berkeley

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-30 who speak English and are willing to participate. They should have stable sleep medication use if applicable, irregular sleep patterns or late sleep times on weekends, and be 'at risk' in emotional, cognitive, behavioral, physical or social health domains. Excluded are those with substance abuse/dependence, severe mental or physical illness, pregnancy/breastfeeding individuals, certain sleep disorders unless treated.

Inclusion Criteria

You have challenges in one of the five areas of health: emotions, thinking, behavior, physical health, or social interactions. This is measured by scoring 4 or higher on a specific scale.

My sleep medication dose has been the same for at least 4 weeks.

I often sleep late or my sleep schedule varies by 2+ hours.

Exclusion Criteria

I might have sleep issues like sleep apnea or restless legs but haven't been diagnosed or treated yet.

You work at night at least twice a week between midnight and 6am.

If you have a mental or physical condition that would make it difficult for you to take part in the study or if there is a high risk of harm if the treatment for your other condition is delayed because of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Habit-based Sleep Health Intervention with or without text messages, consisting of 3x50-minute weekly sessions followed by 6x30-minute weekly sessions

9 weeks

9 visits (in-person)

Post-treatment Follow-up

Participants are monitored for sleep health behavior and circadian outcomes at 1-week post-treatment

1 week

Long-term Follow-up

Participants are monitored for sleep health behavior and circadian outcomes at 6 and 12 months post-treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Habit-based Sleep Health Intervention
• Text messaging intervention

Trial Overview

The study tests a habit-based sleep-health intervention aimed at improving participants' quality of rest through the science of habit formation. It also examines whether adding text message reminders enhances this process.

How Is the Trial Designed?

Group I: Habit-based Sleep Health Intervention plus text messages (HABITs+texts) Experimental Treatment 2 Interventions

Participants in this condition participate in the HABITs intervention which includes 3x50-minute weekly sessions followed by 6x30-minute weekly sessions. Additionally, participants in this group will receive the text messaging intervention.

Group II: Habit-based Sleep Health Intervention (HABITs) Experimental Treatment 1 Intervention

Participants in this condition participate in the HABITs intervention which includes 3x50-minute weekly sessions followed by 6x30-minute weekly sessions. Participants in this group will not receive the texts discussed below.

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials

193

Recruited

716,000+

Published Research Related to This Trial

A study involving 31 Japanese office workers showed that receiving objective push-type sleep feedback improved sleep timing and reduced physical symptoms like fatigue and neck stiffness, indicating potential benefits for overall well-being.

While the feedback group experienced better mood and physical symptom scores upon waking, there were no significant differences in daily work performance, suggesting that while sleep feedback can enhance certain aspects of health, it may not directly impact work productivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Objective Push-Type Sleep Feedback on Habitual Sleep Behavior and Momentary Symptoms in Daily Life: mHealth Intervention Trial Using a Health Care Internet of Things System. Takeuchi, H., Suwa, K., Kishi, A., et al.[2022]

The app-based intervention 'Refresh' significantly improved sleep quality in participants with insomnia symptoms, showing a medium effect size (d=0.45) in those with poor sleep, and these improvements were maintained at a 6-month follow-up.

Despite its effectiveness, about one-third of participants did not access the intervention, highlighting the need for better strategies to enhance uptake and adherence to app-based sleep interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an App-Based Short Intervention to Improve Sleep: Randomized Controlled Trial. Vollert, B., Müller, L., Jacobi, C., et al.[2023]

A mobile app designed to deliver sleep restriction therapy (SRT) was found to be highly acceptable and engaging for individuals with insomnia, with participants logging an average of 19 sleep diary entries over 21 days.

Participants showed significant improvements in insomnia severity, sleep efficiency, and daytime symptoms like fatigue and sleepiness, indicating the app's potential efficacy as a treatment for insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study of a mobile app to treat insomnia. Aji, M., Glozier, N., Bartlett, D., et al.[2021]

A text-message intervention aimed at promoting sleep hygiene was tested on 96 college students over 6 weeks, showing improvements in sleep quality and hygiene in both the intervention and control groups, although these changes were not statistically significant.

The study suggests that enhancing self-efficacy for sleep hygiene could be a key factor in improving sleep quality, indicating that text messaging is a practical method for encouraging healthy behaviors among young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a sleep hygiene text message intervention on sleep in college students. Gipson, CS., Chilton, JM., Dickerson, SS., et al.[2020]

A study involving 176 participants (9 in focus groups and 167 in an online survey) identified that users with poor sleep prefer personalized features in a sleep app, such as sleep diaries and alarms, to enhance engagement and effectiveness.

Most participants (93%) expressed willingness to try an evidence-based sleep app, highlighting the importance of tailoring app functionalities to user needs, especially for those with severe insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring User Needs and Preferences for Mobile Apps for Sleep Disturbance: Mixed Methods Study. Aji, M., Gordon, C., Peters, D., et al.[2020]

A study analyzed 35 popular sleep apps and found that they only incorporated behavioral theory constructs at a low average of 34%, indicating a significant opportunity for improvement in promoting effective sleep hygiene practices.

The most common behavioral constructs included realistic goal setting (86%), time management (77%), and self-monitoring (66%), but there was no statistically significant correlation between the presence of these constructs and user ratings, suggesting that app effectiveness may not solely depend on behavioral theory integration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep apps and behavioral constructs: A content analysis. Grigsby-Toussaint, DS., Shin, JC., Reeves, DM., et al.[2020]

The SleepSync mobile app significantly improved various sleep-related outcomes for shift workers, including total sleep time, ability to fall asleep, and sleep quality, based on a trial with 27 participants over two weeks.

Users reported positive engagement and usability with the app, indicating it effectively integrated into their routines and influenced their sleep behaviors, suggesting its potential as a valuable tool for managing sleep in shift workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile app for personalized sleep-wake management for shift workers: A user testing trial. Murray, JM., Magee, M., Giliberto, ES., et al.[2023]

A study involving 27 young participants (ages 14-18) from diverse backgrounds revealed that while they were interested in using smartphone apps to improve sleep, they faced barriers such as reluctance to change sleep routines on weekends and concerns about using electronics at bedtime.

Feedback on two commercially available sleep apps was generally positive, indicating good adherence and perceived health benefits, suggesting that app-based interventions could be effective if tailored to the specific needs and preferences of young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Qualitative Assessment of the Acceptability of Smartphone Applications for Improving Sleep Behaviors in Low-Income and Minority Adolescents. Quante, M., Khandpur, N., Kontos, EZ., et al.[2023]

A significant portion of adults in the US experience sleep deficiency, with 50-70 million affected by sleep disorders, which can negatively impact health and workplace productivity.

The dayzz app, a personalized sleep training program, will be tested in a randomized trial to assess its effectiveness in improving sleep quality and employee performance, potentially offering a scalable solution for sleep health education and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical trial to evaluate the dayzz smartphone app on employee sleep, health, and productivity at a large US employer. Robbins, R., Weaver, MD., Quan, SF., et al.[2023]

An online 10-week course significantly increased university students' sleep knowledge from a mean score of 3.0 to 4.2 out of 5, with 91% reporting greater knowledge at the 6-month follow-up.

While the course improved students' attitudes towards sleep and reduced sleep latency from 33.3 to 25.6 minutes, it did not lead to significant changes in overall sleep quality or behaviors, indicating a need for more comprehensive behavioral change strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an Online Sleep and Circadian Education Program on University Students' Sleep Knowledge, Attitudes, and Behaviours. Semsarian, CR., Rigney, G., Cistulli, PA., et al.[2021]

A new mobile health tool called SLEEPKit was developed to help hospitalized patients identify and address their specific sleep disruptors, using icons and tailored sleep promotion tips created through a participatory approach involving patients, families, and clinicians.

The iterative feedback process led to icons that were well-understood by both patients and clinicians, and the sleep promotion strategies were deemed feasible and effective for improving sleep in acute care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized sleep promotion in acute care hospitals: managing specific factors that affect patient sleep. Ye, L., Dykes, PC.[2022]

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