Effect of Treating Sleep Apnea on Cognition in Patients With Dementia

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00477828
Study type	Interventional
Source	University of California, San Diego
Contact
Status	Completed
Phase	N/A
Start date	April 2000
Completion date	January 2006

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.