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

NCT ID: NCT02034357

Last Updated: 2016-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2016-03-31

Brief Summary

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.

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.

Conditions

Parkinson's Disease; Sleep Disordered Breathing; Sleep Obstructive Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Neurocognitive function

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Parkinson Foundation

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Carlos Singer

Division Chief Parkinson Disease and Movement Disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos Singer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

References

Shafazand S, Wallace DM, Arheart KL, Vargas S, Luca CC, Moore H, Katzen H, Levin B, Singer C. Insomnia, Sleep Quality, and Quality of Life in Mild to Moderate Parkinson's Disease. Ann Am Thorac Soc. 2017 Mar;14(3):412-419. doi: 10.1513/AnnalsATS.201608-625OC.

Reference Type: DERIVED

PMID: 28231027 (View on PubMed)

Other Identifiers

20110265

Identifier Type: -

Identifier Source: org_study_id