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Completed

NCT Number: NCT02034357

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurocognitive function

Other

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.

Sleep evaluations

Other

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Parkinson Foundation

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2016
First posted
Jan 13, 2014
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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