Telehealth Program for Sleep Disorders

(SWISH Trial)

Overseen By Liudmyla Kozii, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon State University

Must not be taking: Chronic sleep-interfering medications

Disqualifiers: Substance use disorder, Thought disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those with chronic use of medications that interfere with sleep. If you're using such medications, you might not be eligible to participate.

What data supports the effectiveness of the treatment Shift Worker Intervention for Sleep Health?

Research shows that an online cognitive behavioral therapy for insomnia (CBT-I) significantly improved sleep efficiency, wellbeing, and reduced insomnia and depression symptoms in shift workers, indicating its potential effectiveness for sleep health in this group. ^{1 2 3 4 5}

Is the Telehealth Program for Sleep Disorders safe for humans?

The research indicates that shift work and sleep disorders can have health risks, but there are management strategies like melatonin treatment and light exposure that are generally safe and can help improve sleep and alertness. It's important to avoid inappropriate use of sedatives and wakefulness-promoters, and to consider individual differences in response to shift work. ^{2 6 7 8 9}

How does the Shift Worker Intervention for Sleep Health treatment differ from other treatments for sleep disorders?

The Shift Worker Intervention for Sleep Health is unique because it is specifically tailored for shift workers, focusing on non-drug approaches like online cognitive behavioral therapy for insomnia (CBT-I) and individualized coaching programs. These methods aim to improve sleep efficiency and overall wellbeing by addressing the unique challenges faced by shift workers, such as circadian misalignment and irregular sleep schedules. ^{1 3 5 10 11}

What is the purpose of this trial?

The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers.

Research Team

Jessica Dietch, PhD

Principal Investigator

Oregon State University

Eligibility Criteria

This trial is for nurses in Oregon, aged 18-65, who work night shifts or rotating shifts including nights at least three times a week and have been doing so for over three months. Participants must have internet access, be able to read/write in English, consent to the study, expect to continue shift work, and report poor sleep. Excluded are those on certain medications or treatments affecting sleep, with substance abuse issues or severe psychiatric conditions.

Inclusion Criteria

Have daily access to the internet on a smartphone, table, or computer; and

Currently employed as a nurse in the state of Oregon

Can read and write in English.

Exclusion Criteria

Currently participating in other research studies with substantial overlap in terms of methods/procedures (e.g., PI's ongoing study 'Piloting an Adaptation of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)'

Conditions which make study treatment likely to be ineffective. For example, current chronic use of medications that interfere with sleep, alcohol or substance use disorder, or thought disorder (as determined by DIAMOND psychiatric interview), unstable sleep or medical conditions that necessitate additional medical care not provided by study treatments (e.g., known untreated sleep apnea)

Presence of safety risk or condition in which study participation may result in increased risk to safety (e.g., elevated risk for suicide, self-reported uncontrolled seizure disorder, history of manic or hypomanic episode, current pregnancy)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the SWISH intervention, a multicomponent behavioral therapy for insomnia, administered via telehealth across approximately weekly sessions

12 weeks

Weekly sessions (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Shift Worker Intervention for Sleep Health

Trial Overview The 'SWISH' program is being tested as a telehealth intervention aimed at improving sleep health among shift workers. It's personalized and uses media through devices like smartphones or computers to help manage the unique challenges of shift work-related sleep disturbances.

Participant Groups

Group I: SWISH Experimental Treatment 1 Intervention

SWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia. Other Names: Cognitive Behavioral Therapy for Insomnia

Group II: WLC Active Control 1 Intervention

Waitlist Control: Participants in the delayed treatment control condition will begin the SWISH intervention following completion of the posttreatment time point.

Who Is Running the Clinical Trial?

Oregon State University

Lead Sponsor

Trials

51

Recruited

8,300+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

A 4-week online cognitive behavioral therapy for insomnia (CBT-I) significantly improved sleep efficiency by 7.2% in a group of 21 shift workers, showing it as a feasible treatment option.

Both online and face-to-face CBT-I interventions led to significant improvements in sleep quality and wellbeing, with no notable difference in effectiveness between the two methods, indicating that online therapy can be as effective as traditional in-person treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Online CBT-I Intervention and a Face-to-Face Treatment for Shift Work Sleep Disorder: A Comparison of Sleep Diary Data. Peter, L., Reindl, R., Zauter, S., 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 systematic review of 68 studies on interventions for shiftworkers found that only 60.3% assessed implementation, highlighting a gap in understanding how these interventions are applied in real-world settings.

The average quality of implementation assessment was moderate (2.56 out of 5), and only a small number of studies identified enablers (25%) or barriers (26.5%) to effective implementation, suggesting that future research should focus more on these aspects to improve intervention effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of interventions designed to promote healthy sleep and circadian rhythms in shiftworkers. Harrison, EM., Schmied, EA., Yablonsky, AM., et al.[2021]

Shift work affects nearly 20% of the global labor force and is linked to negative impacts on worker health, safety, and quality of life due to disruptions in circadian rhythms and increased sleepiness during shifts.

Management strategies for shift work disorder (SWD) include promoting better sleep and wakefulness, but more research is needed to understand the health risks and develop effective treatments for those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shift work and the assessment and management of shift work disorder (SWD). Wright, KP., Bogan, RK., Wyatt, JK.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of an Online CBT-I Intervention and a Face-to-Face Treatment for Shift Work Sleep Disorder: A Comparison of Sleep Diary Data. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Diagnosis and management of sleep disorders in shift workers, with patient informed solutions to improve health services research and practice. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Evidence summary on the non-pharmacological management of sleep disorders in shift workers. [2023]

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

Mobile app for personalized sleep-wake management for shift workers: A user testing trial. [2023]

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

Implementation of interventions designed to promote healthy sleep and circadian rhythms in shiftworkers. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Sleep complaints and polysomnographic findings: a study of nuclear power plant shift workers. [2015]

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

Shift work and the assessment and management of shift work disorder (SWD). [2022]

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

Shift work disorder case studies: applying management principles in clinical practice. [2013]

9. Australia pubmed.ncbi.nlm.nih.gov

Sleep loss and circadian disruption in shift work: health burden and management. [2022]

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

The effectiveness of an individualized sleep and shift work education and coaching program to manage shift work disorder in nurses: a randomized controlled trial. [2023]

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

Pilot Test of "NIOSH Training for Law Enforcement on Shift Work and Long Work Hours". [2022]