Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742182
• Other study ID #: Circadian Rhythms in PD
• Secondary ID: 1K23NS072283-01A
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: June 2018

Study information

• Verified date: February 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Disruption of sleep and alertness is one of the most disabling non-motor symptoms of Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not well understood, and treatment options remain limited. The proposed research will examine markers of the circadian system, sleepiness and sleep quality in PD patients and healthy controls. Further, the project will examine effects of bright light exposure on circadin function, sleep and alertness in PD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria;

2. PD Hoehn and Yahr stage 2-4;

3. Pittsburgh Sleep Quality Index (PSQI) score >5 in group 1, and =5 in group 2;

4. Epworth Sleepiness Scale (ESS) score =10 in group 1, and <10 in group 2;

Control participants will be matched for gender and age with PD participants.

Exclusion Criteria:

1. Atypical or secondary forms of Parkinsonism;

2. Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of = 26;

3. Presence of depression defined as the Beck Depression Inventory (BDI) score >14;

4. Use of hypno-sedative drugs for sleep or stimulants; participants will be allowed to taper these drugs and will become eligible at least 4 weeks after the taper is completed;

5. Use of SSRIs / SNRIs antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening;

6. Use of medications known to affect melatonin secretion;

7. Unstable/serious medical illness.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Light exposure

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	circadian rhythm of melatonin		June 2012- May 2017
Primary	Sleep Efficiency		June 2012- May 2017
Primary	Daytime Somnolence		June 2012- May 2017