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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sonia Ancoli-Israel, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00492115
First received: June 26, 2007
Last updated: June 17, 2013
Last verified: June 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Benefits of Treating Sleep Apnea in Dementia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Tests to examine memory; 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 ]

Enrollment: 96
Study Start Date: July 2007
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
CPAP
Device: Continuous positive airway pressure (CPAP)
therapeutic CPAP
Placebo Comparator: B
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 in memory and cognitive function, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
UCSD
San Diego, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Sonia Ancoli-Israel, PhD University of California, San Diego
  More Information

Publications:
Responsible Party: Sonia Ancoli-Israel, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00492115     History of Changes
Other Study ID Numbers: AG08415
Study First Received: June 26, 2007
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
sleep
dementia
apnea
memory
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 20, 2014