Treating Sleep Wake Cycle Disturbances in Huntington's Disease Subjects With Ramelteon

Condition(s) targeted: Huntington's Disease; Sleep Disorders; Circadian Dysregulation

Intervention: Ramelteon (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Kaloyan S Tanev, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Kaloyan S Tanev, MD, Phone: 617-726-7511, Email: ktanev@partners.org

The investigators are conducting a study of the medication Ramelteon in persons between the ages of 20 and 65 who have tested positive for Huntington Disease (HD) and are complaining of trouble sleeping. This study is designed to determine the effects of 4 weeks Ramelteon treatment on the sleep patterns of people with HD. The study also aims to look at the sleep patterns of caregivers of people with HD.

Official title: Treating Sleep Wake Cycle Disturbances in Huntington's Disease Subjects With Ramelteon - a Double Blind, Placebo Controlled Trial

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Sleep efficiency and other actigraphy derived sleep parameters

Secondary outcome: HD-related neurological measures, cognitive measures, mood symptoms, aggression measures, functional ability.

Detailed description: Previous studies on sleep patterns in Huntington's Disease (HD) subjects suggest that there are sleep/wake cycle abnormalities in HD subjects, that these abnormalities are probably related to the severity of HD symptoms, and that they lead to distress for HD patients and their caregivers alike. The proposed study is a double-blind, placebo controlled pilot study of HD subjects with sleep disturbances. It aims to assess the effects of Ramelteon, a drug that functions as a melatonin receptor agonist, on sleep patterns in HD subjects. Additionally, the study attempts to determine whether sleep wake disturbances in HD subjects are associated with sleep wake disturbances in their caregivers. The study will use actigraphy as an objective measure of sleep wake cycles.

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects will be between the ages of 20 and 65 years old.

- Subjects will have subjective complaints of problem sleeping or their caregivers will

complain of the subjects not sleeping well

- Subjects with all severity of HD symptoms will be accepted as long as they complain

of sleep problems

- Positive HD gene status for everyone except the caregivers will have been obtained

for clinical reasons and will be known at the time of enrollment into the study

Exclusion Criteria:

- Subjects below the age of 20 or above 65 years old

- Subjects who are unable to participate in the informed consent process

- Subjects with previously documented primary sleep disorders (unrelated to HD),

including Obstructive Sleep Apnea Syndrome, Periodic Limb Movement Disorder of Sleep, or Narcolepsy

- Subjects who perform shift work or have any other circadian rhythm abnormality or

disruption

- Subjects who are diagnosed with a Major Depressive Episode, current at the time of

enrollment (subject may have a history of a Major Depressive Episode as long as it is in partial or full remission at the time of enrollment)

- Subjects who are diagnosed with a manic or hypomanic episode, current at the time of

enrollment (subject may have a history of a manic or hypomanic episode as long as it is in full remission at the time of enrollment)

- Subjects who at the time of enrollment receive hypnotic agents or have been on

hypnotic agents during the two weeks prior to enrollment

- Subjects who are pregnant at the time of enrollment or intend to become pregnant

during the period of study participation

- Subjects who in the opinion of the research personnel would not be able to

participate in the research protocol because of agitation, lack of transportation, or other reasons.

Kaloyan S Tanev, MD, Phone: 617-726-7511, Email: ktanev@partners.org

Massachusetts General Hospital, Boston, Massachusetts 02144, United States; Recruiting
Kaloyan S Tanev, MD, Phone: 617-726-7511, Email: ktanev@partners.org
Angela Hu, Phone: 617-726-5486, Email: ahu1@partners.org
Kaloyan S Tanev, MD, Principal Investigator

Related publications:

Hurelbrink CB, Lewis SJ, Barker RA. The use of the Actiwatch-Neurologica system to objectively assess the involuntary movements and sleep-wake activity in patients with mild-moderate Huntington's disease. J Neurol. 2005 Jun;252(6):642-7. Epub 2005 Mar 7.

Morton AJ, Wood NI, Hastings MH, Hurelbrink C, Barker RA, Maywood ES. Disintegration of the sleep-wake cycle and circadian timing in Huntington's disease. J Neurosci. 2005 Jan 5;25(1):157-63. Erratum in: J Neurosci. 2005 Apr 13;25(15):3994.

Ancoli-Israel S, Clopton P, Klauber MR, Fell R, Mason W. Use of wrist activity for monitoring sleep/wake in demented nursing-home patients. Sleep. 1997 Jan;20(1):24-7.

Starting date: May 2009
Ending date: May 2011
Last updated: May 21, 2009