Sleep Disordered Breathing and Its Impact on Neuro-cognitive Performance and Quality of Life in Parkinson Disease

Overview

The purpose of this study is to determine the impact of sleep and breathing problems during sleep on memory, attention, and general well being (quality of life) in people with Parkinson Disease.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2013

Detailed Description

During the 2 year award period, we will prospectively enroll 200 patients with idiopathic Parkinson Disease (PD), who meet eligibility criteria below. All patients will undergo a baseline polysomnography (PSG) to diagnose Sleep Disordered Breathing (SDB) and will be asked to complete validated questionnaires to measure Sleep Quality, SDB risk, insomnia severity, daytime sleepiness, presence of restless leg syndrome (RLS), anxiety/depression, and quality of life. Medical records will be reviewed to determine co-morbidities and medication use. Each PD participant will undergo a full neurological examination, including the Unified Parkinson's Disease Rating Scale (UPDRS), the Hoehn & Yahr stage and a battery of neuro-cognitive measures at baseline. Patients with SDB will be offered PAP titration and treatment for 4 months. All patients (SDB [PAP compliant, non-compliant], and no SDB [controls]) will complete repeat neuro-cognitive evaluation, questionnaires, neurological evaluation and UPDRS assessment at 4 month and at 1 year follow-up. PD participants will be assessed in the "on" state in the morning. In the event that a participant goes "off" during testing, a break will be taken and participants will be given the option of taking their medication to return to the "on" state and resume testing or they can return later in the week to complete the evaluation. Although participants will understand the general purpose of the study, they will be blinded to the major study hypothesis. Neuropsychological examiners and the neurologist conducting the neurological exam will be blinded to the SDB status of the patient. Four month follow-up will be staggered according to enrolment date and will be completed by Year 2.

Interventions

  • Other: Neurocognitive function
    • Each eligible participant will complete a neuro-cognitive assessment as measured by CVLT at the beginning of the study. Neurocognitive evaluations will be repeated at 4-month and 1-year follow-up.
  • Other: Sleep evaluations
    • Each eligible participant will complete sleep questionnaires and undergo a baseline sleep study at the beginning of the study. The sleep questionnaires will be repeated at 4-month and 1-year follow-up.

Arms, Groups and Cohorts

  • Other: Neurocognitive function
    • Neurocognitive function assessment (verbal learning and memory) as measured by CVLT and sleep evaluations in Parkinson’s disease patients at baseline, and after 4 months and 1 year of CPAP treatment

Clinical Trial Outcome Measures

Primary Measures

  • Changes from Baseline Neurocognitive function in Parkinson’s disease patients at 4 month and 1 year follow-up as measured by California Verbal Learning Test (CVLT)
    • Time Frame: Baseline, week 4, year 1
    • Changes from Baseline Neurocognitive function (verbal learning and memory) in Parkinson’s disease patients at 4 month and 1 year follow-up as measured by California Verbal Learning Test (CVLT).

Secondary Measures

  • Prevalence of Sleep Disordered Breathing (SDB) in a diverse cohort of idiopathic PD patients.
    • Time Frame: Baseline
    • Determine the Prevalence of Sleep Disordered Breathing (SDB) in a diverse cohort of idiopathic PD patients.
  • Prevalence of Insomnia in a diverse cohort of idiopathic PD patients.
    • Time Frame: Baseline
    • Prevalence of Insomnia in a diverse cohort of idiopathic PD patients.
  • Prevalence of Poor Sleep Quality in a diverse cohort of idiopathic PD patients.
    • Time Frame: Baseline
    • Prevalence of Poor Sleep Quality in a diverse cohort of idiopathic PD patients.

Participating in This Clinical Trial

Inclusion Criteria

  • Able to give consent.
  • ≥18 years and have a Hoehn and Yahr stage at the time of enrollment of ≤3, clinical diagnosis of idiopathic Parkinson's Disease meeting the United Kingdom Parkinson's Disease Society Brain Bank criteria.
  • Stable medical condition, including medications in the 1 month prior to enrollment.

Exclusion Criteria

  • Previous diagnosis of SDB with active use of Positive Airway Pressure (PAP), surgery for SDB or tracheostomy.
  • Inability to read and comprehend English and/or Spanish at a grade 5 level.
  • Prior history of neurosurgical procedures for PD or any other condition.
  • Diagnosis of dementia as defined by Mini-mental state examination (MMSE) of < 26.
  • History of major uncontrolled psychiatric illness.
  • History of drug or alcohol abuse/dependence.
  • History of major head injury or other neurological disease.
  • Patients with observable craniofacial abnormalities that may be a relative contraindication to PAP.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Miami
  • Collaborator
    • National Parkinson Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Carlos Singer, Division Chief Parkinson Disease and Movement Disorders – University of Miami
  • Overall Official(s)
    • Carlos Singer, MD, Principal Investigator, University of Miami

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