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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01742182

Enrollment

Registered

2012-12-05

Start date

2012-06-30

Completion date

2018-06-30

Last updated

2020-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease, Excessive Daytime Sleepiness, Circadian Rhythms, Light Therapy

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.

Interventions

OTHERLight exposure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
circadian rhythm of melatonin	June 2012- May 2017
Sleep Efficiency	June 2012- May 2017
Daytime Somnolence	June 2012- May 2017

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026