Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Melatonin
  • 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.
Placebo Comparator
Placebo
  • 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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Erin Furr Stimming, MD
713-500-7033
Erin.E.Furr@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Erin Furr Stimming, MD
7135007033
Erin.E.Furr@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.