Status:
RECRUITING
Slow Wave Sleep As a Biomarker of Rehabilitation-induced Cognitive Improvement in PD
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Parkinson Disease
Eligibility:
All Genders
45-100 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the effects of exercise rehabilitation on cognition and to evaluate slow wave sleep (SWS) as a biomarker and mediator of response to rehabilitation-induced ...
Detailed Description
Sleep impairment adversely affects cognitive function and increases risk for dementia. Slow wave sleep (SWS) or delta sleep (non-rapid eye movement (REM) stage 3; N3) is especially important for cogni...
Eligibility Criteria
Inclusion
- Inclusion:
- clinical diagnosis of idiopathic PD, based on the presence of bradykinesia as well as at least one of the following: rest tremor, rigidity, and/or postural instability (per United Kingdom PD Brain Bank Criteria)
- Hoehn and Yahr stage 2-3 (performed at screening visit)
- age ≥ 45 and
- on stable medications for at least 4 weeks prior to study entry without expecting to change medications for the duration of the study.
- Montreal Cognitive Assessment (MoCA) score ≥ 18 and \<26 (performed at screening visit)
- No contraindications to an exercise program.
- Exclusion:
- fails exercise readiness evaluation at screening visit
- regular participation in an exercise program
- cardiovascular or pulmonary disease, including uncontrolled hypertension, congestive heart failure, unstable coronary artery disease, serious arrhythmia, stroke within the past year, or chronic obstructive pulmonary disease (COPD)
- shift workers
- signs indicative of atypical Parkinsonism (cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs)
- secondary Parkinsonism (neuroleptic treatment at time of onset of Parkinsonism or at time of study entry, history of multiple strokes with stepwise progression of Parkinsonism, or history of multiple head injuries)
- inability to walk without assistance
- deep brain stimulation (DBS)
- known narcolepsy
- untreated sleep apnea
- any condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures.
Exclusion
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04796506
Start Date
July 1 2021
End Date
March 31 2026
Last Update
October 1 2024
Active Locations (1)
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1
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States, 80045