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Cognitive Benefits of Treating Sleep Apnea in Parkinson's Disease (TAP)

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ClinicalTrials.gov Identifier: NCT00492115
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : June 4, 2018
Last Update Posted : July 23, 2019
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Sonia Ancoli-Israel, University of California, San Diego

Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson's Disease Sleep Disordered Breathing Device: Continuous positive airway pressure (CPAP) Device: Placebo CPAP Not Applicable

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 in memory and cognitive function, will be administered before the start of treatment, after three weeks, and after six weeks of treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Benefits of Treating Sleep Apnea in Dementia
Study Start Date : July 2007
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: therapeutic CPAP Treatment (6 weeks)"
Intervention - The active comparator is an intervention of nightly therapeutic CPAP (continuous positive airway pressure) treatment for 6 weeks. Patients will use CPAP every night for the full duration of the study, i.e., 6 weeks
Device: Continuous positive airway pressure (CPAP)
therapeutic Continuous positive airway pressure (tCPAP) nightly for 6 weeks

Placebo Comparator: Sham CPAP/therapetuic CPAP (6 weeks)"

The placebo comparator is an intervention of placebo CPAP (continuous positive airway pressure) nightly for 3 weeks followed by therapeutic CPAP treatment nightly for 3 weeks.

Patients will use a sham CPAP (no real pressure) for 3 weeks and then will be switched to real CPAP for 3 weeks.

Device: Placebo CPAP
Ineffective Continuous positive airway pressure (pCPAP) for 3 weeks followed by therapeutic CPAP for 3 weeks

Primary Outcome Measures :
  1. Tests to Determine the Apnea-hypopnea Index (Number of Apneas and Hypopneas Per Hour of Sleep) [ Time Frame: six weeks ]
    Overnight sleep studies were done to determine the effect of treatment on the apnea-hypopnea index (number of apneas and hypopneas per hour of sleep)

Secondary Outcome Measures :
  1. Sleep Stages; %Time Spent at SaO2<90%; [ Time Frame: 6 weeks ]
    Overnight sleep studies were done to examine the effect of CPAP treatment on sleep stages and on %time spent at Sa)2<90%.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492115

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United States, California
San Diego, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
National Institute on Aging (NIA)
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Principal Investigator: Sonia Ancoli-Israel, PhD University of California, San Diego
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sonia Ancoli-Israel, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00492115    
Other Study ID Numbers: AG08415
R01AG008415 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2007    Key Record Dates
Results First Posted: June 4, 2018
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sonia Ancoli-Israel, University of California, San Diego:
Parkinson's disease
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders