Effect of Treating Sleep Apnea on Cognition in Patients With Dementia

NCT00477828 | Completed

• 1 other identifier: R01AG008415
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Sleep Apnea

Keywords

sleep apnea; dementia; excessive sleepiness; cognition

Outcome Measures

Primary Outcomes (1)

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

  three weeks

Secondary Outcomes (1)

• Caregivers' reports about their sleep

  3 weeks

Interventions

Continuous positive airway pressure DEVICE

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of California San Diego

San Diego, California, 92093, United States

Location

Related Publications (5)

• 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.

  PMID: 17083302 RESULT

• 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.

  PMID: 16872233 RESULT

• 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.

  PMID: 16696743 RESULT

• 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.

  PMID: 16473983 RESULT

• 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.

  PMID: 18795985 DERIVED

MeSH Terms

Conditions

Dementia; Sleep Apnea Syndromes; Disorders of Excessive Somnolence

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Sonia Ancoli-Israel, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 22, 2007
• First Posted: May 24, 2007
• Study Start: April 1, 2000
• Study Completion: January 1, 2006
• Last Updated: May 24, 2007

Record last verified: 2007-05

Locations

US (1)