RECRUITING

Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)

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Conditions

Sleep Apnea SyndromeObstructive Sleep ApneaCOPDOverlap SyndromeQuality of LifeNeurocognitive FunctionSleepinessElderlyPositive Airway PressureApneaSleep Apnea SyndromesSleep Apnea, ObstructiveNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratorycognitive function

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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

Obstructive sleep apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD) are highly prevalent chronic respiratory diseases in the Veteran population. OSA co-occurring with COPD, known as Overlap Syndrome (OVS), is a complex chronic medical condition associated with grave consequences. OVS is highly prevalent in Veterans. Veterans with OVS may be at increased risk for cognitive deficits, poor sleep quality as well as a reduced quality of life (QoL). The overall objective is to study the effects of positive airway pressure therapy on clinical outcomes in patients with OVS.

Official Title

Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)

Quick Facts

Study Start:2020-12-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04179981

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * OSA with moderate-to-severe disease, AHI 20 per hour by in-lab polysomnography with concomitant moderate-severe COPD based on pulmonary function tests (PFTS) and with past significant history (\>10 pack-years) of smoking
  2. * Male or female gender
  3. * Age greater than or equal to 60 years
  4. * Stable treatment regimen for COPD
  1. * Current or prior treatment with PAP or oral appliance
  2. * Central sleep apnea defined as central apnea index \>5 per hour and comprising 50% of AHI
  3. * Known primary neuromuscular diseases
  4. * Disorders that may impact cognitive function including:
  5. * neurodegenerative disorders
  6. * traumatic brain injury
  7. * untreated PTSD and/or history of learning disability
  8. * Medicines that may cause or alter sleepiness: sedative hypnotics, or stimulants as these may alter the results
  9. * Patient is actively suicidal due to depression, unstable mental health condition
  10. * Epworth sleepiness score \>16 (severe sleepiness) or a near-miss or prior automobile accident due to sleepiness within the past 12 months
  11. * Narcolepsy is the primary sleep disorder, with requirement of stimulant medications
  12. * Employed as a commercial driver or operating heavy machinery
  13. * On long-term oxygen therapy prior to start of study, more than 12 hr/day
  14. * Patients is unable to use either a nasal or face mask (e.g., facial trauma, claustrophobia)
  15. * Consumption of \>3 alcoholic beverages per day or current use of some illicit drugs, as these may contribute to cognitive deficits
  16. * Patients who cannot give informed consent
  17. * Patients receiving hospice care
  18. * Pregnant women due to unknown risks

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)

VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
United States
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 Date2020-12-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2020-12-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Apnea
  • Sleep Apnea Syndromes
  • Sleep Apnea, Obstructive
  • Nervous System Diseases
  • Respiration Disorders
  • Respiratory Tract Diseases
  • Signs and Symptoms, Respiratory
  • positive airway pressure
  • cognitive function
  • quality of life
  • sleepiness

Additional Relevant MeSH Terms

  • Sleep Apnea Syndrome
  • Obstructive Sleep Apnea
  • COPD
  • Overlap Syndrome
  • Quality of Life
  • Neurocognitive Function
  • Sleepiness
  • Elderly
  • Positive Airway Pressure