Morning Light Treatment for Inflammatory Bowel Disease

Overseen By Muneer Rizvydeen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Photosensitizing medications

Disqualifiers: Chronic disease, Psychotic, Bipolar, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether morning light treatment can ease symptoms of inflammatory bowel disease (IBD). One group of participants will have a daily morning light session for an hour, while another group will maintain their usual routines. The researchers aim to determine if adjusting sleep timing and light exposure can improve IBD symptoms. This study suits individuals with biopsy-confirmed IBD who experience active symptoms affecting their quality of life. Participants must be able to travel for study visits and speak English fluently. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for IBD patients.

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 prior data suggests that morning light treatment is safe for inflammatory bowel disease?

Research shows that morning light treatment is usually easy for people to handle. It improves sleep by exposing individuals to light early in the day. Although specific safety studies aren't mentioned, this method is non-invasive, meaning it doesn't involve surgery or entering the body. In other areas, such as treating mood disorders, light therapy has shown very few side effects. Mild side effects, like headaches or eye strain, can occur but are rare. Since this treatment doesn't use drugs, it generally poses fewer risks compared to medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for inflammatory bowel disease, which often involves medications like aminosalicylates, corticosteroids, and immunosuppressants, the morning light treatment is a non-invasive approach using natural light. It’s unique because it leverages the body’s circadian rhythms to potentially reduce inflammation and improve symptoms. Researchers are excited about this method because it offers a novel, side-effect-free alternative that could complement existing treatments and enhance overall patient well-being.

What evidence suggests that morning light treatment might be an effective treatment for inflammatory bowel disease?

Research suggests that morning light treatment, a treatment under study in this trial, might benefit people with inflammatory bowel disease (IBD). This treatment resets the body's internal clock, potentially reducing inflammation and improving IBD symptoms. Some studies have shown that morning light therapy can stabilize the body's natural daily cycle. This stability may lead to better sleep and reduced disease activity. Although more research is needed, these early findings indicate promising benefits for those with IBD. Participants in this trial will receive either the morning light treatment or continue with their usual treatment regimen. ^{1 2 4 5 6}

Who Is on the Research Team?

Helen Burgess, Ph.D.

Principal Investigator

University of Michigan

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

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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

I can travel for study visits.

Fluency in English

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Morning light treatment
• Treatment-as-usual

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.

How Is the Trial Designed?

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+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11110384/

Morning light treatment for inflammatory bowel disease Morning light treatment, which advances and stabilizes circadian timing, may have the potential to improve IBD symptoms and disease activity, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06676488

A Randomized Crossover Trial of Bright Light Therapy in ... Our overall objective is to assess the effects of morning bright light therapy on IBS symptom severity, circadian misalignment, intestinal permeability and ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38778264/

Morning light treatment for inflammatory bowel disease Morning light treatment, which advances and stabilizes circadian timing, may have the potential to improve IBD symptoms and disease activity, ...

4. researchgate.net researchgate.net/publication/380788591_Morning_light_treatment_for_inflammatory_bowel_disease_a_clinical_trial

(PDF) Morning light treatment for inflammatory bowel disease Morning light treatment, which advances and stabilizes circadian timing, may have the potential to improve IBD symptoms and disease activity, ...

5. withpower.com withpower.com/trial/phase-crohn-disease-10-2023-06ee8

Morning Light Treatment for Inflammatory Bowel Disease Since light therapy can help regulate circadian rhythms, it might improve sleep and potentially benefit IBD patients by reducing inflammation and improving ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/443356

A Pilot Study Looking at Changes in Sleep Timing and IBD ... This research study is testing whether changes in sleep timing and morning light treatment may have an impact on symptoms related to ...