Cognitive Benefits of Treating Sleep Apnea in Parkinson's Disease

NCT ID: NCT00492115

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2013-05-31

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.

Conditions

Parkinson's Disease; Sleep Disordered Breathing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

therapeutic CPAP Treatment (6 weeks)"

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

Group Type: ACTIVE_COMPARATOR

Continuous positive airway pressure (CPAP)

Intervention Type: DEVICE

therapeutic Continuous positive airway pressure (tCPAP) nightly for 6 weeks

Sham CPAP/therapetuic CPAP (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.

Group Type: PLACEBO_COMPARATOR

Placebo CPAP

Intervention Type: DEVICE

Ineffective Continuous positive airway pressure (pCPAP) for 3 weeks followed by therapeutic CPAP for 3 weeks

Interventions

Continuous positive airway pressure (CPAP)

therapeutic Continuous positive airway pressure (tCPAP) nightly for 6 weeks

Intervention Type: DEVICE

Placebo CPAP

Ineffective Continuous positive airway pressure (pCPAP) for 3 weeks followed by therapeutic CPAP for 3 weeks

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Sonia Ancoli-Israel

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonia Ancoli-Israel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

UCSD

San Diego, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 17083302 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16696743 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16473983 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27448468 (View on PubMed)

Other Identifiers

R01AG008415

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AG08415

Identifier Type: -

Identifier Source: org_study_id