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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
89
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.
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.
University of Miami
Miami, Florida, United States
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)
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).
Time frame: Baseline, week 4, year 1
Prevalence of Sleep Disordered Breathing (SDB) in a diverse cohort of idiopathic PD patients.
Determine the Prevalence of Sleep Disordered Breathing (SDB) in a diverse cohort of idiopathic PD patients.
Time frame: Baseline
Prevalence of Insomnia in a diverse cohort of idiopathic PD patients.
Prevalence of Insomnia in a diverse cohort of idiopathic PD patients.
Time frame: Baseline
Prevalence of Poor Sleep Quality in a diverse cohort of idiopathic PD patients.
Prevalence of Poor Sleep Quality in a diverse cohort of idiopathic PD patients.
Time frame: Baseline
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