Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study

Huntington Disease Clinical Trial

Official title:

Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421339
• Other study ID #: HSC-MS-19-1111
• Status: Completed
• Phase: N/A
• Start date: January 22, 2021
• Est. completion date: September 16, 2022

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the efficacy of exogenous melatonin in improving sleep quality in HD gene carriers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 16, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Verified HD mutation carriers.
• Patients who report sleep disturbance as measured by a score =5 on the Pittsburgh Sleep Quality Index (PSQI);
• Stable concomitant medication (no change of medication during last 30 days prior to inclusion);
• Written informed consent by prospective study participant before conduct of any trial-related procedure;
• Participant must be able to make an informed decision of whether or not to participate in the study.

Exclusion Criteria:

• Pregnant or nursing women;
• Woman of childbearing potential, not using highly effective methods of contraception such as oral, topical or injected contraception, intrauterine device (IUD), contraceptive vaginal ring, or double barrier method such as diaphragm and condom with spermicide) or not surgically sterile (via hysterectomy, ovariectomy or bilateral tubal ligation) or not at least one year post menopausal;
• Presence of any medically not controllable disease (e.g. uncontrolled arterial hypertension or diabetes mellitus);
• Use of benzodiazepines, sedating antidepressants (mirtazapine or trazodone) or sedating antipsychotics (olanzapine and quetiapine) in the previous four weeks;
• Severe cognitive disorders defined as a score < 18 on the MOCA;
• Participation in another investigative drug trial within 2 months;
• Subjects who are unlikely to be compliant and attend scheduled clinic visits as required as determined by the Investigator.

Related Conditions & MeSH terms

• Dyssomnias
• Huntington Disease
• Parasomnias

Intervention

Dietary Supplement:
• Melatonin
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.

Other:
• Placebo
Participants will receive placebo once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Huntington's Disease Society of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, week 5, week 9
Secondary	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.	Baseline, week 5, week 9
Secondary	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.	Baseline, week 5, week 9
Secondary	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.	Baseline, week 5, week 9
Secondary	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.	Baseline, week 5, week 9
Secondary	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".	Baseline, week 5, week 9