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Effect of Treating Sleep Apnea on Cognition in Patients With Dementia

Primary Purpose

Dementia, Sleep Apnea

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

About this trial

This is an interventional supportive care trial for Dementia focused on measuring sleep apnea, dementia, excessive sleepiness, cognition

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Mild probable Alzheimer's disease (diagnosed according to the National Institute of Neurological and Communicative Disorders & Stroke-Alzheimer's Disease and Related Disorders Association [NINCDS-ADRDA] criteria).
  • Mini Mental Status Exam score between 20 and 27
  • Respiratory disturbance index >15 (i.e., 15 apneas plus hypopneas per hour of sleep) - Between the ages of 50-85 years
  • Stable health
  • reliable caregiver
  • English speaking
  • Patients will be allowed to continue 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 study.

Exclusion Criteria:

  • Currently receiving treatment for sleep apnea.
  • Apneas primarily central in origin; narcolepsy or other sleep disorders
  • Medication known to influence sleep (i.e. sedative hypnotics, narcotics) will be excluded if the dose can not remain stable and unchanged 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, history of psychosis, or current alcohol or drug abuse
  • Current diagnosis of active uncontrolled seizure disorder
  • Any other advanced, severe and unstable disease of any type that may put the subject at special risk or interfere with primary and secondary variable evaluations
  • Change in any medication within one month of participation.

Sites / Locations

  • University of California San Diego

Outcomes

Primary Outcome Measures

cognitive functioning; reports of daytime sleepiness; reports of quality of sleep

Secondary Outcome Measures

Caregivers' reports about their sleep

Full Information

First Posted
May 22, 2007
Last Updated
May 22, 2007
Sponsor
University of California, San Diego
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00477828
Brief Title
Effect of Treating Sleep Apnea on Cognition in Patients With Dementia
Official Title
Cognitive Benefits of Treating Apnea in Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

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
The purpose of this study is to determine whether treating sleep apnea with continuous positive airway pressure would result in improvements in cognition in patients with Alzheimer's disease.
Detailed Description
Patients with sleep disordered breathing (SDB) experience nighttime sleep fragmentation and often become hypoxic during the night. The fragmentation and hypoxemia can frequently result in daytime impairments including impairments in cognitive functioning. The state-of-the-art treatment for SDB is Continuous Positive Airway Pressure (CPAP). Many SDB patients who are successfully treated with CPAP show improvement in memory and other cognitive functions. Data have shown that there is a strong relationship between SDB and dementia with patients with Alzheimer's Disease (AD) having a high rate of SDB. This proposal will examine whether treating SDB with CPAP in patients with AD will result in improvement in cognitive functioning. The specific aims are to assess whether patients with mild AD and SDB will tolerate CPAP and be compliant with treatment; to examine the effect of CPAP treatment on SDB in patients with mild AD and SDB; to examine the effect of CPAP treatment on cognitive functioning in patients with mild AD and SDB; to examine whether improvement is greater after six weeks of CPAP treatment than after three weeks of treatment. Since caregivers are often disturbed by the patients poor sleep, we will also evaluate the effect of the patients' treatment on their caregivers. Specifically, the secondary aims are to evaluate whether caregivers feel that CPAP improves the patient's sleep and to evaluate whether caregivers feel that their own sleep improves as the patient's sleep improves. Patient identified as having mild AD and SDB will have an extensive neuropsychological battery. Half will be randomized to CPAP treatment and the other half to shamCPAP. After three weeks neuropsychological tests will be repeated. The shamCPAP will be switched to CPAP and the CPAP group will remain on CPAP for an additional three weeks. Neuropsychological tests will again be repeated. The long-term goal of this line of research is to find a new approach that might improve the quality of life, delay the dementing process, postpone institutionalization and save millions of dollars in nursing care costs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Sleep Apnea
Keywords
sleep apnea, dementia, excessive sleepiness, cognition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure
Primary Outcome Measure Information:
Title
cognitive functioning; reports of daytime sleepiness; reports of quality of sleep
Time Frame
three weeks
Secondary Outcome Measure Information:
Title
Caregivers' reports about their sleep
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Mild probable Alzheimer's disease (diagnosed according to the National Institute of Neurological and Communicative Disorders & Stroke-Alzheimer's Disease and Related Disorders Association [NINCDS-ADRDA] criteria). Mini Mental Status Exam score between 20 and 27 Respiratory disturbance index >15 (i.e., 15 apneas plus hypopneas per hour of sleep) - Between the ages of 50-85 years Stable health reliable caregiver English speaking Patients will be allowed to continue 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 study. Exclusion Criteria: Currently receiving treatment for sleep apnea. Apneas primarily central in origin; narcolepsy or other sleep disorders Medication known to influence sleep (i.e. sedative hypnotics, narcotics) will be excluded if the dose can not remain stable and unchanged 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, history of psychosis, or current alcohol or drug abuse Current diagnosis of active uncontrolled seizure disorder Any other advanced, severe and unstable disease of any type that may put the subject at special risk or interfere with primary and secondary variable evaluations Change in any medication within one month of participation.
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
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

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
16872233
Citation
Cooke JR, Loredo JS, Liu L, Marler M, Corey-Bloom J, Fiorentino L, Harrison T, Ancoli-Israel S. Acetylcholinesterase inhibitors and sleep architecture in patients with Alzheimer's disease. Drugs Aging. 2006;23(6):503-11. doi: 10.2165/00002512-200623060-00005.
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
18795985
Citation
Ancoli-Israel S, Palmer BW, Cooke JR, Corey-Bloom J, Fiorentino L, Natarajan L, Liu L, Ayalon L, He F, Loredo JS. Cognitive effects of treating obstructive sleep apnea in Alzheimer's disease: a randomized controlled study. J Am Geriatr Soc. 2008 Nov;56(11):2076-81. doi: 10.1111/j.1532-5415.2008.01934.x. Epub 2008 Sep 15.
Results Reference
derived

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Effect of Treating Sleep Apnea on Cognition in Patients With Dementia

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