Actively Recruiting

Phase Not Applicable
Age: 45Years - 100Years
All Genders
NCT04796506

Slow Wave Sleep As a Biomarker of Rehabilitation-induced Cognitive Improvement in PD

Led by University of Colorado, Denver · Updated on 2024-10-01

120

Participants Needed

1

Research Sites

247 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 improvement in cognitive performance among persons with Parkinson's disease (PwP), with the ultimate goal of maximizing rehabilitation efficacy at the individual level (i.e. precision rehabilitation).

CONDITIONS

Official Title

Slow Wave Sleep As a Biomarker of Rehabilitation-induced Cognitive Improvement in PD

Who Can Participate

Age: 45Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of idiopathic Parkinson's disease with bradykinesia plus rest tremor, rigidity, or postural instability
  • Hoehn and Yahr stage 2-3 as assessed at screening
  • Age 45 years or older
  • Stable Parkinson's medications for at least 4 weeks before study start with no expected changes
  • Montreal Cognitive Assessment score between 18 and less than 26
  • No contraindications to exercise program
Not Eligible

You will not qualify if you...

  • Failed exercise readiness evaluation at screening
  • Regular participation in an exercise program
  • Cardiovascular or pulmonary disease including uncontrolled hypertension, congestive heart failure, unstable coronary artery disease, serious arrhythmia, stroke within past year, or chronic obstructive pulmonary disease
  • Shift workers
  • Signs of atypical Parkinsonism such as cerebellar signs, gaze palsy, apraxia, autonomic failure, or other cortical signs
  • Secondary Parkinsonism caused by neuroleptic treatment, multiple strokes, or multiple head injuries
  • Inability to walk without assistance
  • Deep brain stimulation
  • Known narcolepsy
  • Untreated sleep apnea
  • Any condition that would prevent safe or successful study participation in the investigator's opinion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

A

Amy W Amara, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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