The purpose of the study is to evaluate the efficacy of exogenous melatonin in improving sleep quality in HD gene carriers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
Participants will receive melatonin 5 mg once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over.
Participants will receive placebo once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Change in sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 9-question instrument used to measure the quality and patterns of sleep in adults. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper.
Time frame: Baseline, week 5, week 9
Improvement in sleep quality, as assessed by the Huntington's disease (HD) sleep questionnaire
This questionnaire contained 45 questions that focused on different sleep-related issues such as duration, quality of sleep, abnormal nocturnal behavior and quality of life. The questionnaire has a total score of 19 points, scores of (0 - 3) represent the 'normal' range whilst, scores of (4 - 6) reflect 'mild' and scores of 7 and above indicate a 'significant' sleep disturbance.
Time frame: Baseline, week 5, week 9
Improvement in daytime somnolence, as evaluated by the Epworth Sleepiness Scale (ESS)
The ESS is a questionnaire designed to measure the subject's general level of daytime sleepiness. This scale scores from 0-24, with higher scores showing severe excessive daytime sleepiness.
Time frame: Baseline, week 5, week 9
Improvement in self-perceived cognitive function, as assessed by the Quality of Life in Neurological Disorders questionnaire (NeuroQOLv2.0) Cognition Function - Short Form
It is an 8-question instrument designed and validated to evaluate perceived difficulties in cognitive abilities (e.g., memory, attention, and decision making, or in the application of such abilities to everyday tasks (e.g., planning, organizing, calculating, remembering and learning). The score ranges from 0-100, with higher scores meaning a better or worse outcome according to the domain evaluated.
Time frame: Baseline, week 5, week 9
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Improvement in global cognitive functioning, as assessed by the Montreal cognitive assessment (MoCA)
The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.
Time frame: Baseline, week 5, week 9
Improvement in quality of life, as evaluated by the Huntington's Disease Quality of Life Questionnaire (HDQoL)
It is a disease-specific scale containing 40 questions, with answers including different types of frequency from "never" to "all of the time".
Time frame: Baseline, week 5, week 9