Cognitive Benefits of Treating Sleep Apnea in Parkinson's Disease

NCT00492115 | Completed Results

• 2 other identifiers: AG08415R01AG008415
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Sleep Disordered Breathing

Keywords

sleep; dementia; apnea; memory; Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• 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)

  six weeks

Secondary Outcomes (1)

• Sleep Stages; %Time Spent at SaO2<90%;

  6 weeks

Study Arms (2)

therapeutic CPAP Treatment (6 weeks)"

ACTIVE COMPARATOR

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

Device: Continuous positive airway pressure (CPAP)

Sham CPAP/therapetuic CPAP (6 weeks)"

PLACEBO COMPARATOR

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.

Device: Placebo CPAP

Interventions

Continuous positive airway pressure (CPAP) DEVICE

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

therapeutic CPAP Treatment (6 weeks)"

Placebo CPAP DEVICE

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

Sham CPAP/therapetuic CPAP (6 weeks)"

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

UCSD

San Diego, California, 92093, United States

Location

Related Publications (4)

• 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

• 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

• 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.

  PMID: 27448468 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Sleep Apnea Syndromes; Dementia; Apnea

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Sonia Ancoli-Israel
• Organization: UCSD

sancoliisrael@ucsd.edu

858 822 7710

Study Officials

• Sonia Ancoli-Israel, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 27, 2007
• Study Start: July 1, 2007
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 23, 2019
• Results First Posted: June 4, 2018

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)