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

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: Light exposure

• Registration Number: NCT01742182
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-05
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-15
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PD patients with sleep problems	Light exposure	light exposure
PD patients with sleep problem	Light exposure	light exposure

Primary Outcome Measures

Name	Time	Method
Sleep Efficiency	June 2012- May 2017
circadian rhythm of melatonin	June 2012- May 2017
Daytime Somnolence	June 2012- May 2017

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States