Inflammatory Bowel DiseasesNCT06094608
IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms
A study testing Morning light treatment and Treatment-as-usual in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by University of Michigan at 1 site in United States.
Trial summary
This research study is testing whether changes in sleep timing and morning light treatment may have an impact on symptoms related to inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Morning light treatment and Treatment-as-usual
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 24 Jun 2026
- 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
- Biopsy-proven IBD
- Active IBD symptoms
- Impaired IBD quality of life
- Age >/=18 years old
- Fluency in English
- Physically able to travel for study visits
Who cannot join
- Ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses, are planned for imminent surgery and/or have short bowel syndrome
- Other significant chronic disease
- Retinal pathology, history of eye surgery, taking photosensitizing medications
- Recent history of light treatment
- Lifetime psychotic or bipolar disorder
- Acute suicidal ideation
Show all 11Show fewer
- Substance use disorder in the past 3 months, cannabis use >1/week
- High risk for or diagnosed with obstructive sleep apnea, and/or narcolepsy
- Severe hearing problem, intellectual disability or serious cognitive impairment
- Pregnant, trying to get pregnant, or breastfeeding
- Night work or travel outside the eastern time zone in the past month
Trial locations and contacts
1 site in 1 country.
About this study
This research study is testing whether changes in sleep timing and morning light treatment may have an impact on symptoms related to inflammatory bowel disease.
Read the detailed description
This study will test a consumer health light therapy device (Re-Timer) for people with inflammatory bowel disease to better understand how it affects IBD-related quality of life.
- Being tested
- Morning light treatment, Treatment-as-usual
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning light treatmentDevice
Also called Re-Timer®
Light therapy via the Re-Timer. Participants will conduct light treatment in the mornings at home for one hour using Re-timer®.
Treatment-as-usualBehavioural
Participants will not make modifications to their activities or sleep schedule.
| Study group | Role | What they receive |
|---|---|---|
| Morning light treatment | Experimental | A 1 hour per day morning light treatment starting at average wake time, or up to 1 hour earlier to accommodate the morning schedule. The daily treatment continues for 4 weeks. Receives: Device: Morning light treatment |
| Treatment-as-usual | Active comparator | Participants will be instructed to continue to follow their usual sleep schedule for 4 weeks. Receives: Behavioral: Treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short IBD Questionnaire (SIBDQ) score
SIBDQ is 10 questions, each with a Likert like scale with 7 options and lower scores indicate poorer quality of life.
Measured: Baseline, post-treatment approximately 36 days
Secondary outcomes (4)
Change in Patient Health Questionnaire 9 (PHQ-9) score
PHQ-9 is a depression score ranging from 0 through 27. No depression 0-4, mild 5-9, moderate 10-14, moderately severe 15-19, severe 20-27.
Measured: Baseline, post-treatment approximately 36 days
Change in Patient-Reported Outcomes Measurement Information System Sleep Disturbance (PROMIS) Short-Form 8b
PROMIS Sleep Disturbance measures self-reported sleep quality during the past seven days. The measure includes 8-items with higher scores indicating greater sleep disturbance.
Measured: Baseline, post-treatment approximately 36 days
For patients with Crohn's Disease (CD) - Change in Harvey Bradshaw Index (HBI)
The HBI is a clinician-rated measure of disease severity in Crohn's disease (CD). The HBI has items addressing a range of symptoms including general well-being, abdominal pain, liquidity/softness of stool, presence of an abdominal mass and complications. The total score reflects the following: score <5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and >16 = severe disease activity.
Measured: Baseline, post-treatment approximately 36 days
For patients with Ulcerative Colitis (UC) - Change in Simple Clinical Colitis Activity Index (SCCAI)
The SCCAI is a clinician-rated measure of disease severity in ulcerative colitis (UC). The SCCAI has items addressing a range of symptoms from bowel frequency, defecation urgency, blood in stool, general well-being, and other extracolonic disease features. Scores range from 0 to 19 points, and scores < or equal to 2.5 indicate clinical remission.
Measured: Baseline, post-treatment approximately 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Feb 2024
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Burgess, University of Michigan
- Investigators
- Helen Burgess, Ph.D., Principal investigator, University of MichiganCathy Goldstein, M.D., M.S., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094608
- Sponsor's protocol ID
- HUM00234262
- Other IDs
- 1R01DK136520
- Status last verified
- Aug 2026
- First submitted
- 16 Oct 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The researchers are open to sharing data by any appropriate mechanism indicated by NIH program staff.
Publications
Cohen-Mekelburg S, Goldstein CA, Rizvydeen M, Fayyaz Z, Patel PJ, Berinstein JA, Bishu S, Cushing-Damm KC, Kim HM, Burgess HJ. Morning light treatment for inflammatory bowel disease: a clinical trial. BMC Gastroenterol. 2024 May 22;24(1):179. doi: 10.1186/s12876-024-03263-2.
PubMed 38778264
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms
- ClinicalTrials.gov ID
- NCT06094608
- Acronym / sponsor ID
- HUM00234262
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 23 Oct 2023 (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.
This research study is testing whether changes in sleep timing and morning light treatment may have an impact on symptoms related to inflammatory bowel disease.
Detailed description
This study will test a consumer health light therapy device (Re-Timer) for people with inflammatory bowel disease to better understand how it affects IBD-related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning light treatment | Experimental | Device: Morning light treatmentA 1 hour per day morning light treatment starting at average wake time, or up to 1 hour earlier to accommodate the morning schedule. The daily treatment continues for 4 weeks. |
| Treatment-as-usual | Active comparator | Behavioral: Treatment-as-usualParticipants will be instructed to continue to follow their usual sleep schedule for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Biopsy-proven IBD
- Active IBD symptoms
- Impaired IBD quality of life
- Age >/=18 years old
- Fluency in English
Key exclusion criteria (11 listed)
- Ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses, are planned for imminent surgery and/or have short bowel syndrome
- Other significant chronic disease
- Retinal pathology, history of eye surgery, taking photosensitizing medications
- Recent history of light treatment
- Lifetime psychotic or bipolar disorder
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 |
|---|---|---|
| Morning light treatmentAlso: Re-Timer®Light therapy via the Re-Timer. Participants will conduct light treatment in the mornings at home for one hour using Re-timer®. | Device | Morning light treatment |
| Treatment-as-usualParticipants will not make modifications to their activities or sleep schedule. | Behavioural | Treatment-as-usual |
Primary outcome
Change in Short IBD Questionnaire (SIBDQ) score
Time frame: Baseline, post-treatment approximately 36 days
SIBDQ is 10 questions, each with a Likert like scale with 7 options and lower scores indicate poorer quality of life.
4 secondary outcomes
Change in Patient Health Questionnaire 9 (PHQ-9) score
Time frame: Baseline, post-treatment approximately 36 days
Change in Patient-Reported Outcomes Measurement Information System Sleep Disturbance (PROMIS) Short-Form 8b
Time frame: Baseline, post-treatment approximately 36 days
For patients with Crohn's Disease (CD) - Change in Harvey Bradshaw Index (HBI)
Time frame: Baseline, post-treatment approximately 36 days
For patients with Ulcerative Colitis (UC) - Change in Simple Clinical Colitis Activity Index (SCCAI)
Time frame: Baseline, post-treatment approximately 36 days
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 1 Sep 2026.
- Derived from this study: PubMed 38778264Cohen-Mekelburg S, Goldstein CA, Rizvydeen M, Fayyaz Z, Patel PJ, Berinstein JA, Bishu S, Cushing-Damm KC, Kim HM, Burgess HJ. Morning light treatment for inflammatory bowel disease: a clinical trial. BMC Gastroenterol. 2024 May 22;24(1):179. doi: 10.1186/s12876-024-03263-2.
- Individual participant dataSharing planned: Yes. The researchers are open to sharing data by any appropriate mechanism indicated by NIH program staff.
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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.
Helen Burgess, Ph.D. principal investigator
University of Michigan
Cathy Goldstein, M.D., M.S. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning light treatment and Treatment-as-usual in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by University of Michigan 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 11 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 1 Sep 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?
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?
Change in Short IBD Questionnaire (SIBDQ) score (time frame: Baseline, post-treatment approximately 36 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06094608, which also lists 1 linked publication.
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 1 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.