Cognitive Benefits of Treating Sleep Apnea in Parkinson's Disease - Full Text View

Sponsors and Collaborators:	University of California, San Diego National Institute on Aging (NIA)
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00492115

Purpose

Patients with sleep disordered breathing (SDB), also called sleep apnea, experience nighttime disrupted sleep and, because they stop breathing for short periods during the night, do not get sufficient oxygen to their brains. This can frequently result in daytime impairments including difficulties with memory. The state-of-the-art treatment for SDB is Continuous Positive Airway Pressure (CPAP). Many non-demented SDB patients who are successfully treated with CPAP show improvement in memory and other cognitive functions. Data have shown that patients with Parkinson's disease have a high rate of SDB. Patients with Parkinson's disease also often have problems with memory. This study will test the effects of treating SDB among patients with Parkinson's disease and SDB. Specifically, the study will test the effect of CPAP treatment on SDB and sleep; the effect of CPAP treatment on daytime sleepiness, cognition, overall quality of life and mood; the effect of CPAP treatment on the frequency of symptoms of REM behavior disorder and restless legs syndrome; the effect of continued CPAP use (beyond the six weeks of the study) on SDB, sleep, cognition, mood and quality of life; whether the study-partner feels that CPAP improves the patient's sleep, mood and overall functioning; whether study-partners feel that their own sleep, mood and overall functioning improve as the patient's sleep improves both during the 6-week protocol and at follow-up for those opting to continue using CPAP.

Condition	Intervention
Parkinson's Disease Sleep Disordered Breathing	Device: Continuous positive airway pressure (CPAP) Device: Placebo CPAP

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Dementia Memory Parkinson's Disease Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Cognitive Benefits of Treating Sleep Apnea in Dementia

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

Neuropsychological tests; daytime sleepiness [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

sleep, quality of life, daytime sleepiness [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	July 2007
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator CPAP	Device: Continuous positive airway pressure (CPAP) therapeutic CPAP
B: Placebo Comparator Placebo CPAP	Device: Placebo CPAP Ineffective CPAP

Detailed Description:

This study will examine the effect of three weeks vs. six weeks of CPAP treatment on cognitive functioning and sleep in patients with Parkinson's disease and sleep apnea. It is designed as a randomized, double blind, placebo-controlled trial of CPAP. As a comparison group, half the patients will first be randomly assigned to three weeks of shamCPAP, followed by three weeks of therapeutic CPAP treatment. Sleep, functional outcome and mood questionnaires and a repeatable neuropsychological test battery, chosen to be sensitive to the type of changes we expect to find, will be administered before the start of treatment, after three weeks, and after six weeks of treatment.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of dementia due to Parkinson's disease (according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (code 294.1)
MMSE score between 18 and 26, inclusive; cognitive symptoms must occur at least one year after the diagnosis of PDD
Apnea hypopnea index >10 (i.e., 10 apneas plus hypopneas per hour of sleep)
Over the age of 50 years
Stable health
Fluent English speaking
Patients will be allowed to continue dopaminergic medications, acetylcholinesterase inhibitors, psychotropic medications, memory enhancers, health food supplements, etc. as long as they have been stable on the same dose for at least two months prior to participation and agree to continue on this dose for the duration of the 6-week study.

Exclusion Criteria:

Current treatment for sleep apnea (to avoid discontinuing already established treatment for sleep apnea and any carry over confounding effect of treatment on cognition).
Central sleep apnea
Use of medications known to influence sleep (i.e. sedative hypnotics, narcotics) if the dose cannot remain stable for the duration of the study.
Bronchospastic and symptomatic chronic obstructive pulmonary disease as indicated by regular use of bronchodilators, steroids, history of carbon dioxide retention, waking hypoxemia (PaO2 <60 mmHg or SpO2 <92 % by pulse oximetry), or use of supplemental oxygen.
Symptomatic coronary or cerebral vascular disease (history of myocardial infarction, angina, stroke, or transient ischemic attacks), history of life-threatening arrhythmias, cardiomyopathy, or current alcohol or drug abuse
Current diagnosis of active seizure disorder; presence of any neurodegenerative disorder other than PDD or other causes of dementia
Any behavioral or physical problem that would preclude completion of the primary evaluation or treatment with CPAP.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492115

Contacts

Contact: Jana R. Cooke, MD

858 642 3899

jrcooke@ucsd.edu

Locations

United States, California
UCSD	Recruiting
San Diego, California, United States, 92093
Contact: Jana R Cooke, MD
Sub-Investigator: Jody Corey-Bloom, MD
Sub-Investigator: Barton W Palmer, Phd
Sub-Investigator: Jose S Loredo, MD
Sub-Investigator: Loki Natarajan, PhD

Sponsors and Collaborators

University of California, San Diego

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Sonia Ancoli-Israel, PhD

University of California, San Diego

More Information

Publications of Results:

Cooke JR, Liu L, Natarajan L, He F, Marler M, Loredo JS, Corey-Bloom J, Palmer BW, Greenfield D, Ancoli-Israel S. The effect of sleep-disordered breathing on stages of sleep in patients with Alzheimer's disease. Behav Sleep Med. 2006;4(4):219-27.

Chong MS, Ayalon L, Marler M, Loredo JS, Corey-Bloom J, Palmer BW, Liu L, Ancoli-Israel S. Continuous positive airway pressure reduces subjective daytime sleepiness in patients with mild to moderate Alzheimer's disease with sleep disordered breathing. J Am Geriatr Soc. 2006 May;54(5):777-81.

Ayalon L, Ancoli-Israel S, Stepnowsky C, Marler M, Palmer BW, Liu L, Loredo JS, Corey-Bloom J, Greenfield D, Cooke J. Adherence to continuous positive airway pressure treatment in patients with Alzheimer's disease and obstructive sleep apnea. Am J Geriatr Psychiatry. 2006 Feb;14(2):176-80.

Responsible Party:	University of California, San Diego ( Sonia Ancoli-Israel, PhD; Professor )
Study ID Numbers:	AG08415
Study First Received:	June 26, 2007
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00492115
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

sleep
dementia
apnea
memory
Parkinson's disease

Study placed in the following topic categories:

Sleep Apnea Syndromes
Ganglion Cysts
Apnea
Basal Ganglia Diseases
Respiration Disorders
Dyssomnias
Sleep Disorders
Central Nervous System Diseases

Brain Diseases
Neurodegenerative Diseases
Sleep Disorders, Intrinsic
Respiratory Tract Diseases
Parkinson Disease
Movement Disorders
Parkinsonian Disorders
Dementia

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009