Morning Light Treatment for Inflammatory Bowel Disease

Recruiting in Palo Alto (17 mi)

Overseen by Cathy Goldstein, M.D., M.S.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan

Must not be taking: Photosensitizing medications

Disqualifiers: Chronic disease, Psychotic, Bipolar, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking photosensitizing medications (medications that make your skin sensitive to light), you may not be eligible to participate.

What data supports the effectiveness of morning light treatment for inflammatory bowel disease?

Research suggests that poor sleep and disrupted circadian rhythms (the body's internal clock) are common in people with inflammatory bowel disease (IBD). Since light therapy can help regulate circadian rhythms, it might improve sleep and potentially benefit IBD patients by reducing inflammation and improving disease outcomes. ^{1 2 3 4 5}

How does morning light treatment differ from standard care for inflammatory bowel disease?

Morning light treatment is unique because it focuses on improving sleep and circadian rhythms (the body's internal clock) in people with inflammatory bowel disease, which may help reduce inflammation and improve symptoms. This approach is different from standard care, which typically involves medication to directly reduce inflammation. ^{1 2 4 6 7}

Research Team

Helen Burgess, Ph.D.

Principal Investigator

University of Michigan

Cathy Goldstein, M.D., M.S.

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for adults over 18 with biopsy-proven inflammatory bowel disease (IBD) who speak English and can travel for study visits. They should have active IBD symptoms and a reduced quality of life due to IBD. Excluded are those with acute suicidal thoughts, certain gastrointestinal surgeries, pregnancy or breastfeeding, recent night work or travel, other serious chronic diseases, eye conditions or surgery, photosensitizing medication use, recent light treatment history, severe mental health disorders including psychotic or bipolar disorder within a lifetime diagnosis; substance abuse in the past three months; high risk of sleep apnea/narcolepsy; severe hearing issues; intellectual disabilities or significant cognitive impairments.

Inclusion Criteria

My inflammatory bowel disease (IBD) was confirmed through a biopsy.

I am 18 years old or older.

Fluency in English

Exclusion Criteria

You have a significant hearing problem or a condition that affects your ability to think or understand things.

I am at high risk for or have been diagnosed with sleep apnea or narcolepsy.

I have recently undergone light therapy.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 1 hour per day morning light treatment or continue their usual sleep schedule for 4 weeks

4 weeks

Daily self-administered treatment

Follow-up

Participants are monitored for changes in IBD symptoms and quality of life post-treatment

4 weeks

Treatment Details

Interventions

• Morning light treatment (Procedure)
• Treatment-as-usual (Behavioral Intervention)

Trial Overview The study is examining if adjusting sleep patterns and using morning light therapy can improve symptoms in people with ulcerative colitis and Crohn's disease. Participants will either continue their usual treatments without changes (treatment-as-usual) or receive additional morning light treatment to see if there's an effect on their IBD symptoms.

Participant Groups

Group I: Morning light treatment Experimental Treatment 1 Intervention

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.

Group II: Treatment-as-usual Active Control 1 Intervention

Participants will be instructed to continue to follow their usual sleep schedule for 4 weeks.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

The study successfully demonstrated the feasibility of using wrist actigraphy and electronic sleep/activity diaries to measure sleep and circadian rhythms in adults with inflammatory bowel disease (IBD), with 100% participation in wearing actigraphs.

Out of 37 participants, a high completion rate was observed for electronic diaries (91.8%) and saliva collection (91.9%), indicating that these methods are practical for research in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility of Measuring Sleep and Circadian Characteristics in Adults with Inflammatory Bowel Disease. Conley, S., Proctor, DD., Lehner, V., et al.[2021]

In a study analyzing the incidence of Crohn's disease (CD) and ulcerative colitis (UC) across 94 French regions from 2000 to 2002, it was found that lower sunshine exposure is linked to higher rates of CD, suggesting a potential risk factor for the disease.

No significant relationship was observed between sunshine exposure and the incidence of UC, indicating that the protective effect of sunlight may be specific to Crohn's disease rather than inflammatory bowel disease as a whole.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low exposure to sunlight is a risk factor for Crohn's disease. Nerich, V., Jantchou, P., Boutron-Ruault, MC., et al.[2022]

In a study of 42 patients with inactive inflammatory bowel disease (IBD) and 10 healthy controls, those with a history of aggressive IBD showed poorer rest-activity stability and increased fragmentation in their circadian rhythms, suggesting a link between circadian misalignment and more severe disease outcomes.

Circadian misalignment was also associated with increased intestinal permeability, higher levels of pro-inflammatory cytokines like TNF-α, and changes in gut microbiota, indicating that monitoring circadian rhythms could serve as a non-invasive biomarker for inflammation in IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disrupted Circadian Rest-Activity Cycles in Inflammatory Bowel Disease Are Associated With Aggressive Disease Phenotype, Subclinical Inflammation, and Dysbiosis. Swanson, GR., Kochman, N., Amin, J., et al.[2022]

A meta-analysis of 9 studies involving 729 individuals with inflammatory bowel disease (IBD) and 508 healthy controls found that poor sleep is significantly more common in people with inactive IBD compared to healthy individuals, with a moderate effect size (Hedge's g 0.41).

The study highlights the need for further research to explore potential mechanisms, such as subclinical inflammation and psychosocial factors, that may contribute to the poorer sleep quality observed in individuals with IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of sleep quality in inactive inflammatory bowel disease. Barnes, A., Mountifield, R., Baker, J., et al.[2022]

Recent advancements in biologics and immunomodulators have significantly improved the management of inflammatory bowel disease (IBD), allowing for better control of inflammation and healing of mucosal ulcerations, which can potentially modify the disease course and prevent complications.

Despite these advancements, there is still a lack of reliable markers to predict disease progression in IBD patients, making individualized treatment plans essential based on various patient and disease characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current therapeutic approaches in inflammatory bowel disease. Sohrabpour, AA., Malekzadeh, R., Keshavarzian, A.[2022]

LED therapy at a wavelength of 940nm significantly reduced inflammation and tissue damage in mice with induced colitis, suggesting its potential as a therapeutic approach for inflammatory bowel disease.

The treatment not only improved intestinal transit and reduced colon swelling but also decreased levels of inflammatory markers like IL-1β, TNF-α, and IL-6, indicating a strong anti-inflammatory effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light-emitting diodes at 940nm attenuate colitis-induced inflammatory process in mice. Belém, MO., de Andrade, GMM., Carlos, TM., et al.[2017]

In a study of 52 inflammatory bowel disease (IBD) patients, 69.4% with active disease reported poor sleep quality, highlighting a significant link between sleep disturbances and disease activity.

Patients with poor sleep had elevated levels of inflammatory cytokines IL-6, IL-17, and IL-23, suggesting that these cytokines may play a role in both sleep quality and the severity of IBD, indicating potential targets for new therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of the quality of sleep with proinflammatory cytokine profile in inflammatory bowel disease patients. Sobolewska-Włodarczyk, A., Włodarczyk, M., Talar, M., et al.[2022]

References

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

The Feasibility of Measuring Sleep and Circadian Characteristics in Adults with Inflammatory Bowel Disease. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Low exposure to sunlight is a risk factor for Crohn's disease. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Disrupted Circadian Rest-Activity Cycles in Inflammatory Bowel Disease Are Associated With Aggressive Disease Phenotype, Subclinical Inflammation, and Dysbiosis. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of sleep quality in inactive inflammatory bowel disease. [2022]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Current therapeutic approaches in inflammatory bowel disease. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Light-emitting diodes at 940nm attenuate colitis-induced inflammatory process in mice. [2017]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The association of the quality of sleep with proinflammatory cytokine profile in inflammatory bowel disease patients. [2022]