Cognitive Benefits of Treating Sleep Apnea in Parkinson's Disease (TAP)
Parkinson's Disease, Sleep Disordered Breathing
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring sleep, dementia, apnea, memory, Parkinson's disease
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.
Sites / Locations
- UCSD
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
therapeutic CPAP Treatment (6 weeks)"
Sham CPAP/therapetuic CPAP (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
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.