About this trial
Sleep disturbances are common in patients with inflammatory bowel disease (IBD) and are associated with increased disease activity and reduced quality of life. Melatonin, a hormone regulating circadian rhythms, has shown potential anti-inflammatory and sleep-promoting effects in preliminary studies. This study aimed to evaluate the efficacy of melatonin supplementation on sleep quality in IBD patients in clinical remission.
Eligibility criteria
Qualifiers
IBD patients with clinical remission Crohn's disease: HBI < 5 Ulcerative colitis: Partial Mayo score 0-1 w/o bloody stool
Age > 18 years
PSQI score > 5
No medical adjustment for 2 months and use corticosteroids not more than Prednisolone equivalent 5 mg/day
Disqualifiers
Current alcohol or substance abuse
High risk for OSA (STOP-BANG score > 5)
Psychiatric problem: PHQ-9 score > 20 or GAD-7 score > 20
Hypnotic drug use and unable to hold for 1week before trial
Trial design
Treatments tested in this trial
- Melatonin ("Circadin")
- Placebo