Shift-work DisorderSHIFTNCT05186233
Use of Consumer Sleep Technology to Treat Shift Work Disorder
A study testing Phototherapy in people with Shift-work Disorder, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of a personalized light exposure schedule for Shift Work Disorder (SWD) in night shift workers compared to a non-personalized light exposure schedule. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shift-work Disorder
- What is being tested?
- Phototherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Participants must work at least 2 night shifts a week
- Participants must have night shifts starting between 18:00 and 02:00 and lasting 8 to 12 hours
- Participants must have maintained this night shift schedule for at least 6 months
- Participants must have Shift Work Disorder, diagnosed based on ICSD-3 criteria
Who cannot join
- Medical history of central nervous system disorders
- Medical history of other sleep disorders
- Diagnosis of an unstable major medical condition medical chart review
- Dependence on alcohol (≥ 4 beverages a day)
- Heavy tobacco use (≥ 10 cigarettes per day)
- Recreational drug use
Show all 9Show fewer
- Use of medications impacting central nervous system functioning
- Caffeine use in excess of 5-6 servings (~ 600mg) per day
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Columbus Medical Center
Novi, Michigan, 48377
About this study
Official title: Innovations in Wearable Technology for Correcting Circadian Misalignment in Shift Work Disorder
The purpose of this study is to examine the effectiveness of a personalized light exposure schedule for Shift Work Disorder (SWD) in night shift workers compared to a non-personalized light exposure schedule.
Read the detailed description
Participants will be randomized into each condition (n = 25) in a 1:1 ratio. Variables of interest, dim light melatonin onset (DLMO) and shift work disorder (SWD) symptoms, will be assessed before and after the intervention, which will last two weeks. All participants (N=50) will be asked to wear an Apple Watch for two weeks leading up to an in-lab visit. Activity data collection from the Apple Watch will be processed through a mathematical model of the human circadian pacemaker (previously validated in SWD) to generate estimates of DLMO. This two-week period is followed by a 27-hour laboratory visit for pre-treatment assessment of DLMO (hourly saliva melatonin samples over 24 hours). At the end of this visit, participants will receive an orientation to the SHIFT mobile application, where they will be able to assess their prescribed light exposure schedule.
- Conditions
- Shift-work Disorder
- Being tested
- Phototherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyBehavioural
Light exposure recommendations provided by SHIFT mobile application
| Study group | Role | What they receive |
|---|---|---|
| Non-personalized light condition | Active comparator | Participants will receive light exposure recommendations from the SHIFT mobile application based on their habitual sleep schedule. Participants will follow these recommendations over the course of two weeks. Receives: Behavioral: Phototherapy |
| Personalized light condition | Experimental | Participants will receive light exposure recommendations from the SHIFT mobile application based on their activity levels. Participants will follow these recommendations over the course of two weeks. Receives: Behavioral: Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dim light melatonin onset
Melatonin values will be measured in saliva samples, collected in dim light conditions in a laboratory, to determine circadian phase.
Measured: Within two days of treatment for a duration of 24 hours
Secondary outcomes (2)
Insomnia
Insomnia will be measured with the Insomnia Severity Scale (0 to 28; higher scores correspond to worse severity)
Measured: Within one week of post-treatment
Daytime sleepiness
Sleepiness will be measured with the Epworth Sleepiness Scale (0 to 24; a score of 10 or greater indicates excessive daytime sleepiness)
Measured: Within one week of post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start18 Apr 2022
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift-work 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Responsible party
- Principal investigator, Philip Cheng, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186233
- Sponsor's protocol ID
- 15108
- Acronym
- SHIFT
- Status last verified
- Sep 2024
- First submitted
- 15 Dec 2021
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Request for data sharing will be evaluated on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovations in Wearable Technology for Correcting Circadian Misalignment in Shift Work Disorder
- ClinicalTrials.gov ID
- NCT05186233
- Acronym / sponsor ID
- SHIFT / 15108
- Conditions
- Shift-work Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 11 Jan 2022 (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 purpose of this study is to examine the effectiveness of a personalized light exposure schedule for Shift Work Disorder (SWD) in night shift workers compared to a non-personalized light exposure schedule.
Detailed description
Participants will be randomized into each condition (n = 25) in a 1:1 ratio. Variables of interest, dim light melatonin onset (DLMO) and shift work disorder (SWD) symptoms, will be assessed before and after the intervention, which will last two weeks. All participants (N=50) will be asked to wear an Apple Watch for two weeks leading up to an in-lab visit. Activity data collection from the Apple Watch will be processed through a mathematical model of the human circadian pacemaker (previously validated in SWD) to generate estimates of DLMO. This two-week period is followed by a 27-hour laboratory visit for pre-treatment assessment of DLMO (hourly saliva melatonin samples over 24 hours). At the end of this visit, participants will receive an orientation to the SHIFT mobile application, where they will be able to assess their prescribed light exposure schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-personalized light condition | Active comparator | Behavioral: PhototherapyParticipants will receive light exposure recommendations from the SHIFT mobile application based on their habitual sleep schedule. Participants will follow these recommendations over the course of two weeks. |
| Personalized light condition | Experimental | Behavioral: PhototherapyParticipants will receive light exposure recommendations from the SHIFT mobile application based on their activity levels. Participants will follow these recommendations over the course of two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must work at least 2 night shifts a week
- Participants must have night shifts starting between 18:00 and 02:00 and lasting 8 to 12 hours
- Participants must have maintained this night shift schedule for at least 6 months
- Participants must have Shift Work Disorder, diagnosed based on ICSD-3 criteria
Key exclusion criteria (9 listed)
- Medical history of central nervous system disorders
- Medical history of other sleep disorders
- Diagnosis of an unstable major medical condition medical chart review
- Dependence on alcohol (≥ 4 beverages a day)
- Heavy tobacco use (≥ 10 cigarettes per day)
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 |
|---|---|---|
| PhototherapyLight exposure recommendations provided by SHIFT mobile application | Behavioural | Non-personalized light condition, Personalized light condition |
Primary outcome
Dim light melatonin onset
Time frame: Within two days of treatment for a duration of 24 hours
Melatonin values will be measured in saliva samples, collected in dim light conditions in a laboratory, to determine circadian phase.
2 secondary outcomes
Insomnia
Time frame: Within one week of post-treatment
Daytime sleepiness
Time frame: Within one week of post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No. Request for data sharing will be evaluated on a case-by-case basis.
Related trials for Shift-work Disorder
Active, not recruiting
Countermeasures to Circadian Misalignment
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Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
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Breast Cancer Risk Assessment in Night Shift Workers - Implementation of a Personalized Consultation
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Role of Sleep Reactivity in Shift Work Disorder
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phototherapy in people with Shift-work 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 8 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dim light melatonin onset (time frame: Within two days of treatment for a duration of 24 hours). 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 8 Jun 2025.