Melatonin for Huntington's Disease (HD) gene carriers with HD-related sleep disturbance - A pilot study.

BACKGROUND

Sleep disorders are common in people with Huntington's Disease (HD). Possible causes include disruptions to the body's internal clock and changes in melatonin levels. Although melatonin is known to treat sleep disruptions related to circadian rhythm disorders, its effects on HD patients have not been thoroughly explored.

OBJECTIVE

to assess the effectiveness of melatonin in improving the sleep quality of individuals with HD.

METHODS

double-blind, randomized, placebo-controlled, crossover trial with individuals with HD experiencing sleep disturbances, defined as Pittsburgh Sleep Quality Index (PSQI) > 5. Participants received 4-week treatments with 5 mg immediate-release melatonin/placebo, separated by a one-week wash-out (NCT04421339). Clinical assessments were conducted at baseline, week 5 (crossover visit), and week 9 (final visit) and included the PSQI, HD Sleep Questionnaire (HD-SQ), Epworth Sleepiness Scale (ESS), Montreal Cognitive Assessment (MoCA), Neuro-QoL™ v2.0 Cognitive Function, Neuropsychiatric Inventory Questionnaire (NPI-Q), Hospital Anxiety and Depression Scale (HADS), Unified Huntington Disease Rating Scale (UHDRS), and Clinical Global Impression (CGI).

RESULTS

Fifteen patients (46.53 ± 13.92 years old, seven females) completed the study procedures. We found no significant differences between melatonin and placebo treatments in the primary outcome (PSQI), other sleep measures (ESS and HD-SQ), neuropsychiatric symptoms (NPI-Q, HADS, Neuro-QoL, MoCA), and motor/functional measures.

CONCLUSIONS

We found that melatonin did not significantly differ from placebo in improving sleep quality in individuals with HD. Given the conflicting findings from previous research, it may be beneficial to explore alternative dosages of melatonin, increase the sample size, and consider different stages of HD in future studies.