Clinical Trials Directory

Trials / Completed

CompletedNCT06676488

A Randomized Crossover Trial of Bright Light Therapy in Irritable Bowel Syndrome

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
5 (actual)
Sponsor
Medical University of South Carolina · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The purpose of this research study is to assess whether morning bright light therapy (BLT) using a wearable device called a Re-Timer could potentially improve Irritable Bowel Syndrome (IBS) symptoms and decrease intestinal permeability (leaky gut). Morning bright light therapy will be administrated through a safe-wearable glasses device called a Re-Timer. The Re-Timer glasses are lightweight and deliver blue-green light at 500nm, mimicking exposure to natural light.

Detailed description

The hypothesis of this study is that morning bright light therapy (BLT) using Re-Timer™ glasses in irritable bowel syndrome (IBS) patients with circadian misalignment (CM), will improve IBS symptom severity, improve circadian misalignment, decrease intestinal permeability and improve stool microbial diversity. Our overall objective is to assess the effects of morning bright light therapy on IBS symptom severity, circadian misalignment, intestinal permeability and intestinal microbiota. We propose to conduct a 6-week, single center, randomized, crossover pilot trial involving 30 subjects with active IBS symptoms (IBS-SSS \>75), and circadian misalignment (CM) based on late chronotype (Munich Chronotype Questionnaire, Corrected Midpoint of Sleep \> 4:00h). Subjects will be randomized to BLT or placebo with a 2-week washout between each condition. All subjects will have assessments at two timepoints: after 2 weeks of BLT, and after 2 weeks of placebo.

Conditions

Interventions

TypeNameDescription
DEVICERe-Timer glassesMorning bright light therapy (BLT) will be administered through a safe wearable glasses device called a Re-Timer, purchased from the manufacturer Re-Timer.
DEVICEPlacebo DevicePlacebo glasses not providing Bright Light Therapy

Timeline

Start date
2025-06-11
Primary completion
2026-03-31
Completion
2026-03-31
First posted
2024-11-06
Last updated
2026-04-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06676488. Inclusion in this directory is not an endorsement.