Shift Work Sleep DisorderSAILNCT06809335
A Pilot of a Personalized Circadian mHealth to Improve Sleep in Night Shift Workers
A study testing Personalized circadian mHealth in people with Shift Work Sleep Disorder, run by Henry Ford Health System at 1 site in United States.
Trial summary
The goal of this project is to establish the evidence base for equitable accessibility and implementation of the precision sleep medicine mobile application, SHIFT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shift Work Sleep Disorder
- What is being tested?
- Personalized circadian mHealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inadequate sleep duration (habitual sleep less than 7 hours during the day)
- Willingness to download the SHIFT app and follow the lighting recommendations
- Ability to follow a set sleep schedule of 7 hours in bed after the night shifts
- Working at least 4 night shifts a month
- Shifts that must begin between 18:00 and 02:00 and last 8 to 12 hours
- Score of 8 or above on the Epworth Sleepiness scale and/or a score of 8 or above on the Insomnia Severity Index
Who cannot join
- Other independent sleep disorders (e.g., obstructive sleep apnea, narcolepsy, etc.)
- History of seizures or other significant neurological disorders
- Bipolar disorder
- Termination of shift schedule
- Pregnancy
- Current use of medications that impact sleep-wake functioning
- Alcohol and substance use disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Columbus Medical Center
Novi, Michigan, 48377
Philip Cheng, PhD, 248-344-7361, pcheng1@hfhs.org
Marleigh Treger, BS, 248-344-8028, mtreger1@hfhs.org
About this study
The goal of this project is to establish the evidence base for equitable accessibility and implementation of the precision sleep medicine mobile application, SHIFT.
- Conditions
- Shift Work Sleep Disorder
- Being tested
- Personalized circadian mHealth
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized circadian mHealthOther
Also called SHIFT
SHIFT is a mobile application designed to improve sleep in night shift workers. The SHIFT mobile application is used to collect data from an Apple Watch to assess an individual shift worker's body-clock timing and make personalized recommendations of light exposure schedules that are designed to align the body-clock with the night shift work schedule.
| Study group | Role | What they receive |
|---|---|---|
| SHIFT App | Experimental | Participants in this condition will receive an access code to download the mobile application and conduct an orientation to SHIFT and the study procedures with a study team member. They will then enter four weeks of study directed use of SHIFT where they are trained on a daily procedure of opening SHIFT at the beginning of their day and planning their day in accordance with the app recommendations. App usage (4 times per week) will be incentivized with weekly bonuses added to study compensation. Following the four weeks of study-directed use, participants will continue with self-directed use. At four months, participants will then complete a booster session with two additional weeks of study-directed use, followed by self-directed use until the end of the study. The structure with the booster session has evidence for maintaining treatment gains and is also in alignment with the commercialization plan. Receives: Other: Personalized circadian mHealth |
| Waitlist Control | No intervention | Participants in this condition will only complete questionnaires for the initial eight months. Those who remain shift workers will have the option of receiving the SHIFT app and the option to complete follow-up surveys in the same manner as the SHIFT App condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the effect of SHIFT on stakeholder-centered outcomes.
Aim 1a. Measure the effect of SHIFT on work productivity and satisfaction compared to waitlist control using the Job Satisfaction Index. Effect will be tested using a mixed-effects linear regression model with participants as the random effect and Time, Condition, and the Time × Condition interaction term as the fixed effects.
Aim 1b: Measure the effect of SHIFT on global health compared to waitlist control using the NIH PROMIS Global Health questionnaire. Effect will be tested using the same method as Aim 1a.
Aim 1c. Measure the effect of SHIFT on turnover compared to waitlist control, measured at 8-month follow-up. Turnover will be operationalized as an individual who has either terminated the position they were in at baseline or is no longer engaged in shift work as operationalized in the study. Effect will be determined using a generalized mixed-effects regression with turnover as a dichotomous outcome.
Measured: From enrollment to the 8 month point.
Compare use experience and accuracy of SLEEP Android to the original iOS version.
Aim 2a. Measure user experience of Android and iOS versions of SHIFT using the User Experience Questionnaire (UEQ). The following ranges of clinical indifference will be used: ± 3 points on the User Experience Questionnaire based on the bin size of 6 for each of the thresholds (bad, neutral, and good user experience).
Aim 2b. Measure accuracy of predicted circadian misalignment (CM), sleep, and depression in Android and iOS versions. CM will be indexed with the outputs of the biomathematical model of the circadian system. Sleep will be measured using the Insomnia Severity Index and sleep diaries. Depression will be measured using the Quick Inventory of Depressive Symptomatology. The following ranges of clinical indifference will be used: 1) predicted CM = ± 3 hours based on approximately 2x the absolute mean error of our model predictions, 2) insomnia severity = ± 6 points, and 3) depression = 28.5% of the QIDS-SR16 score.
Measured: From enrollment to the 8 month point.
Secondary outcomes (1)
Assess facilitators and barriers to engagement and implementation.
A series of semi-structured interviews will be used for thematic analysis, and a comprehensive roadmap for future app updates based on user feedback. The semi-structured interviews will utilize the interview-guide approach following the CFIR framework selected for this study. Six phases will be followed for thematic analysis: (1) data familiarization, (2) generating initial codes, (3) searching for themes, (4) reviewing themes, (5) defining and naming themes, and (6) producing the report. We will combine deductive and inductive techniques to increase the accuracy of thematic analyses.
Measured: Immediately following completion of 8-month treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start23 Oct 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift Work Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Cheng, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809335
- Sponsor's protocol ID
- 16061
- Acronym
- SAIL
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot of a Personalized Circadian mHealth to Improve Sleep in Night Shift Workers
- ClinicalTrials.gov ID
- NCT06809335
- Acronym / sponsor ID
- SAIL / 16061
- Conditions
- Shift Work Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to establish the evidence base for equitable accessibility and implementation of the precision sleep medicine mobile application, SHIFT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHIFT App | Experimental | Other: Personalized circadian mHealthParticipants in this condition will receive an access code to download the mobile application and conduct an orientation to SHIFT and the study procedures with a study team member. They will then enter four weeks of study directed use of SHIFT where they are trained on a daily procedure of opening SHIFT at the beginning of their day and planning their day in accordance with the app recommendations. App usage (4 times per week) will be incentivized with weekly bonuses added to study compensation. Following the four weeks of study-directed use, participants will continue with self-directed use. At four months, participants will then complete a booster session with two additional weeks of study-directed use, followed by self-directed use until the end of the study. The structure with the booster session has evidence for maintaining treatment gains and is also in alignment with the commercialization plan. |
| Waitlist Control | No intervention | –Participants in this condition will only complete questionnaires for the initial eight months. Those who remain shift workers will have the option of receiving the SHIFT app and the option to complete follow-up surveys in the same manner as the SHIFT App condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Inadequate sleep duration (habitual sleep less than 7 hours during the day)
- Willingness to download the SHIFT app and follow the lighting recommendations
- Ability to follow a set sleep schedule of 7 hours in bed after the night shifts
- Working at least 4 night shifts a month
- Shifts that must begin between 18:00 and 02:00 and last 8 to 12 hours
Key exclusion criteria (7 listed)
- Other independent sleep disorders (e.g., obstructive sleep apnea, narcolepsy, etc.)
- History of seizures or other significant neurological disorders
- Bipolar disorder
- Termination of shift schedule
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized circadian mHealthAlso: SHIFTSHIFT is a mobile application designed to improve sleep in night shift workers. The SHIFT mobile application is used to collect data from an Apple Watch to assess an individual shift worker's body-clock timing and make personalized recommendations of light exposure schedules that are designed to align the body-clock with the night shift work schedule. | Other | SHIFT App |
Primary outcome
Establish the effect of SHIFT on stakeholder-centered outcomes.
Time frame: From enrollment to the 8 month point.
Aim 1a. Measure the effect of SHIFT on work productivity and satisfaction compared to waitlist control using the Job Satisfaction Index. Effect will be tested using a mixed-effects linear regression model with participants as the random effect and Time, Condition, and the Time × Condition interaction term as the fixed effects. Aim 1b: Measure the effect of SHIFT on global health compared to waitlist control using the NIH PROMIS Global Health questionnaire. Effect will be tested using the same method as Aim 1a. Aim 1c. Measure the effect of SHIFT on turnover compared to waitlist control, measured at 8-month follow-up. Turnover will be operationalized as an individual who has either terminated the position they were in at baseline or is no longer engaged in shift work as operationalized in the study. Effect will be determined using a generalized mixed-effects regression with turnover as a dichotomous outcome.
Compare use experience and accuracy of SLEEP Android to the original iOS version.
Time frame: From enrollment to the 8 month point.
Aim 2a. Measure user experience of Android and iOS versions of SHIFT using the User Experience Questionnaire (UEQ). The following ranges of clinical indifference will be used: ± 3 points on the User Experience Questionnaire based on the bin size of 6 for each of the thresholds (bad, neutral, and good user experience). Aim 2b. Measure accuracy of predicted circadian misalignment (CM), sleep, and depression in Android and iOS versions. CM will be indexed with the outputs of the biomathematical model of the circadian system. Sleep will be measured using the Insomnia Severity Index and sleep diaries. Depression will be measured using the Quick Inventory of Depressive Symptomatology. The following ranges of clinical indifference will be used: 1) predicted CM = ± 3 hours based on approximately 2x the absolute mean error of our model predictions, 2) insomnia severity = ± 6 points, and 3) depression = 28.5% of the QIDS-SR16 score.
1 secondary outcome
Assess facilitators and barriers to engagement and implementation.
Time frame: Immediately following completion of 8-month treatment period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized circadian mHealth in people with Shift Work Sleep Disorder, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philip Cheng, PhD (248-344-7361, pcheng1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the effect of SHIFT on stakeholder-centered outcomes. (time frame: From enrollment to the 8 month point.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.