RECRUITING

Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Cognitive dysfunction in the aging Veteran population is a growing health concern in the Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the risk for cognitive dysfunction. The investigators sought to investigate whether these two highly prevalent diseases, that often co-exist as the 'Overlap Syndrome', combine to enhance cognitive impairment in the elderly Veteran population. Thus, the investigators will study whether elderly patients with Overlap syndrome have increased cognitive deficits compared with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP) has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive decline in COPD may be reversible through treatment with long-term oxygen therapy. The investigators will also study whether treatment with positive airway pressure (PAP) and supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life of elderly Veterans.

Official Title

Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD

Quick Facts

Study Start:2016-08-17
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02703207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * OSA defined by the International classification of Sleep Disorders-322 diagnostic criteria with moderate-to-severe disease, i.e. apnea hypopnea index (AHI) 15\* per hour by polysomnography
  2. * Moderate-to-severe COPD defined by GOLD 2 and 3 (Global Obstructive Lung Disease) 23 criteria with FEV1/FVC ratio \<70% and FEV1 \>30% and \<80% of predicted based on PFT done within the past 1 year and a past significant history (10 pack-years) of smoking
  3. * Age 60 years
  4. * Male or female gender
  1. * Mild COPD
  2. * Mild OSA
  3. * Overlap Syndrome with mild OSA plus mild COPD
  4. * Central sleep apnea defined as central apnea index \>5 per hour
  5. * Already on daytime oxygen or nighttime CPAP, NIPPV, oral appliance
  6. * Current smokers
  7. * Pregnant women
  8. * Disorders of hypoventilation due to known neuromuscular or chest wall diseases\*\*
  9. * Patients with significant restrictive lung disease on pulmonary function testing
  10. * Recent admission for any acute illness within the prior 4 months
  11. * Current psychiatric illness requiring sedating medications
  12. * Use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect alertness or daytime functioning for Aim 3/4
  13. * For Aim 3 and 4 only, existing depression as assessed by the PHQ (Patient Health Questionnaire)-9 (score \>10)
  14. * History of learning disability
  15. * Inability to sign consent
  16. * Epworth sleepiness score 18 or a near-miss or prior automobile accident due to sleepiness within the past 12 months
  17. * Patients with unstable heart disease, decompensated heart failure, ejection fraction\<45% or uncontrolled arrhythmias
  18. * Patients unable to use either a nasal or face mask (e.g., facial trauma)
  19. * Consumption of \> 2 alcoholic beverages per day or past history of excessive alcohol use
  20. * Current use of illicit drugs
  21. * Patients who have problems with vision or dexterity and hence, cannot use CPAP/NIPPV
  22. * Life expectancy is less than 6 months

Contacts and Locations

Study Contact

Ruchi Rastogi, MS
CONTACT
(313) 576-4464
ruchi.rastogi@va.gov

Principal Investigator

Susmita Chowdhuri, MD MS
PRINCIPAL_INVESTIGATOR
John D. Dingell VA Medical Center, Detroit, MI

Study Locations (Sites)

John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201-1916
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Susmita Chowdhuri, MD MS, PRINCIPAL_INVESTIGATOR, John D. Dingell VA Medical Center, Detroit, MI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-08-17
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2016-08-17
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • obstructive sleep apnea
  • COPD
  • Overlap syndrome
  • quality of life
  • neurocognitive function
  • sleepiness
  • elderly

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea
  • OSA COPD Overlap Syndrome