NCT04796506Active, not recruiting
Slow Wave Sleep as a Biomarker of Rehabilitation-induced Cognitive Improvement in PD
Slow Wave Sleep as a Biomarker of Rehabilitation-induced Cognitive Improvement in Parkinson's Disease R01 HD100670
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 30 Nov 2020
- Start date
- 1 Jul 2021
- Primary completion date
- 31 May 2027
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Parkinson disease
- NCT number
- NCT04796506
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 1 Jul 2021 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 45 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.