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

Primary Purpose

Parkinson's Disease, Sleep Disordered Breathing

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous positive airway pressure (CPAP)
Placebo CPAP
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring sleep, dementia, apnea, memory, Parkinson's disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

therapeutic CPAP Treatment (6 weeks)"

Sham CPAP/therapetuic CPAP (6 weeks)"

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Tests to Determine the Apnea-hypopnea Index (Number of Apneas and Hypopneas Per Hour of Sleep)
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

Sleep Stages; %Time Spent at SaO2<90%;
Overnight sleep studies were done to examine the effect of CPAP treatment on sleep stages and on %time spent at Sa)2<90%.

Full Information

First Posted
June 26, 2007
Last Updated
July 2, 2019
Sponsor
University of California, San Diego
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00492115
Brief Title
Cognitive Benefits of Treating Sleep Apnea in Parkinson's Disease
Acronym
TAP
Official Title
Cognitive Benefits of Treating Sleep Apnea in Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Sleep Disordered Breathing
Keywords
sleep, dementia, apnea, memory, Parkinson's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
therapeutic CPAP Treatment (6 weeks)"
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham CPAP/therapetuic CPAP (6 weeks)"
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure (CPAP)
Intervention Description
therapeutic Continuous positive airway pressure (tCPAP) nightly for 6 weeks
Intervention Type
Device
Intervention Name(s)
Placebo CPAP
Intervention Description
Ineffective Continuous positive airway pressure (pCPAP) for 3 weeks followed by therapeutic CPAP for 3 weeks
Primary Outcome Measure Information:
Title
Tests to Determine the Apnea-hypopnea Index (Number of Apneas and Hypopneas Per Hour of Sleep)
Description
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)
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Sleep Stages; %Time Spent at SaO2<90%;
Description
Overnight sleep studies were done to examine the effect of CPAP treatment on sleep stages and on %time spent at Sa)2<90%.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Ancoli-Israel, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17083302
Citation
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. doi: 10.1207/s15402010bsm0404_2.
Results Reference
result
PubMed Identifier
16696743
Citation
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. doi: 10.1111/j.1532-5415.2006.00694.x.
Results Reference
result
PubMed Identifier
16473983
Citation
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. doi: 10.1097/01.JGP.0000192484.12684.cd.
Results Reference
result
PubMed Identifier
27448468
Citation
Harmell AL, Neikrug AB, Palmer BW, Avanzino JA, Liu L, Maglione JE, Natarajan L, Corey-Bloom J, Loredo JS, Ancoli-Israel S. Obstructive Sleep Apnea and Cognition in Parkinson's disease. Sleep Med. 2016 May;21:28-34. doi: 10.1016/j.sleep.2016.01.001. Epub 2016 Feb 10.
Results Reference
derived

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Cognitive Benefits of Treating Sleep Apnea in Parkinson's Disease

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