Introduction:
Fatigue is the most common symptom reported by patients with inflammatory bowel disease (IBD), and it impacts patients with both inactive and active disease. There is no treatment for fatigue in patients with inactive IBD despite its significant societal cost. Literature has shown that poor sleep and circadian misalignment (CM) of sleep-wake rhythms can lead to worsening disease activity and flares in patients with IBD. Our study aims to address these unmet needs and treat fatigue and sleep-wake rhythms in patients with inactive Crohn’s Disease (CD) using bright light therapy (BLT).

Methods:
This was a single-center randomized, double-blind crossover study. All subjects were randomized to either: 1) BLT 1 hour each morning for 4 weeks by Re-timer™ or 2) placebo for 4 weeks, with a 4-week washout between each condition. Prior to being randomized to either arm of the study, each subject had two weeks of baseline sleep recorded via wrist actigraphy. Wrist actigraphy was also worn by each subject throughout the duration of the study to calculate markers of CM, including Intradaily Variability (IV) and Interdaily Stability (IS). Questionnaires were administered at three different time points in the study: baseline, condition 1, and condition 2. The questionnaires included the FACIT 4a fatigue questionnaire, the SIBDQ quality of life questionnaire, the PROMIS 8b sleep disturbance questionnaire, and the HBI disease activity questionnaire.

Results:
A total of 13 participants with inactive CD were recruited for the study. Seven of the participants completed the study. Three of the subjects dropped out of the study, and the remaining three were in the process of completing the last phase of the study. The average age of the participants was 37.71 ± 8.32 years, and the average HBI score was 3.88. Eighty-six percent of the subjects were on biologic therapy. There was a significant decrease in IV (p = 0.02) with higher levels associated with CM and a nonsignificant change in IS (p = 0.41), when comparing BLT to baseline (Figure 1). There was a significant decrease in the scores of the FACIT 4a (p = 0.02) and PROMIS 8b sleep questionnaire (p = 0.03) from baseline to BLT (Figure 2a & 2b). Sixty-six percent of subjects noted an improvement in their quality of life after treatment with BLT (p = 0.36) (Figure 2c).

Conclusion:
Our study demonstrated that BLT led to subjective improvement in fatigue and sleep and objective improvement in sleep-wake activity (IV) in participants with inactive CD. To our knowledge, this is the first clinical trial that has shown improvement in fatigue and sleep using a homeopathic approach in patients with inactive CD. Treatment of sleep and fatigue can fill a major therapeutic gap in IBD; however, an increase in the recruitment size and an assessment of the physiologic impact of light therapy are needed.

Garth Swanson

Medical University of South Carolina

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