Phase
Condition
Aging
Sleep Apnea Syndromes
Dermatomyositis (Connective Tissue Disease)
Treatment
Positive airway pressure
Conservative care (control arm)
Clinical Study ID
Ages > 60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
OSA with moderate-to-severe disease, AHI 20 per hour by in-lab polysomnography withconcomitant moderate-severe COPD based on pulmonary function tests (PFTS) and withpast significant history (>10 pack-years) of smoking
Male or female gender
Age greater than or equal to 60 years
Stable treatment regimen for COPD
Exclusion
Exclusion Criteria:
Current or prior treatment with PAP or oral appliance
Central sleep apnea defined as central apnea index >5 per hour and comprising 50% ofAHI
Known primary neuromuscular diseases
Disorders that may impact cognitive function including:
neurodegenerative disorders
traumatic brain injury
untreated PTSD and/or history of learning disability
Medicines that may cause or alter sleepiness: sedative hypnotics, or stimulants asthese may alter the results
Patient is actively suicidal due to depression, unstable mental health condition
Epworth sleepiness score >16 (severe sleepiness) or a near-miss or prior automobileaccident due to sleepiness within the past 12 months
Narcolepsy is the primary sleep disorder, with requirement of stimulant medications
Employed as a commercial driver or operating heavy machinery
On long-term oxygen therapy prior to start of study, more than 12 hr/day
Patients is unable to use either a nasal or face mask (e.g., facial trauma,claustrophobia)
Consumption of >3 alcoholic beverages per day or current use of some illicit drugs,as these may contribute to cognitive deficits
Patients who cannot give informed consent
Patients receiving hospice care
Pregnant women due to unknown risks
Study Design
Study Description
Connect with a study center
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan 48105
United StatesSite Not Available
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan 48201-1916
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.