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

Primary Purpose

Huntington Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Placebo
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington Disease focused on measuring Huntington's Disease, Melatonin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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".

Full Information

First Posted
June 4, 2020
Last Updated
May 12, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Huntington's Disease Society of America
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1. Study Identification

Unique Protocol Identification Number
NCT04421339
Brief Title
Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study
Official Title
Melatonin for Huntington's Disease (HD) Gene Carriers With HD Related Sleep Disturbance - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
September 16, 2022 (Actual)
Study Completion Date
September 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Huntington's Disease Society of America

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
Keywords
Huntington's Disease, Melatonin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over.
Primary Outcome Measure Information:
Title
Change in sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Description
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
Secondary Outcome Measure Information:
Title
Improvement in sleep quality, as assessed by the Huntington's disease (HD) sleep questionnaire
Description
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
Title
Improvement in daytime somnolence, as evaluated by the Epworth Sleepiness Scale (ESS)
Description
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
Title
Improvement in self-perceived cognitive function, as assessed by the Quality of Life in Neurological Disorders questionnaire (NeuroQOLv2.0) Cognition Function - Short Form
Description
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
Title
Improvement in global cognitive functioning, as assessed by the Montreal cognitive assessment (MoCA)
Description
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
Title
Improvement in quality of life, as evaluated by the Huntington's Disease Quality of Life Questionnaire (HDQoL)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Furr Stimming, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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