Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02703207
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea OSA COPD Overlap Syndrome Device: Positive airway pressure Device: NIPPV and /or oxygen Not Applicable

Detailed Description:

OBJECTIVE: Describe the clinical and physiological characteristics of obstructive sleep apnea (OSA) and comorbid chronic obstructive pulmonary disease (COPD) and study the impact of treatment on neurocognitive outcomes in elderly Veterans.

RESEARCH PLAN: The investigators will study if elderly Veterans with OSA and comorbid COPD have increased neurocognitive deficits and sleepiness with reduced quality of life compared to patients with either OSA or COPD alone (Aim 3) and whether treatment with PAP/NIPPV and supplemental oxygen compared to CPAP alone in elderly Veterans with moderate-to-severe OSA and concomitant moderate-to-severe COPD will improve cognitive function, sleepiness and quality of life (QoL).

Aim A: To determine if elderly Veterans with OSA and comorbid COPD have increased neurocognitive deficits and sleepiness compared to patients with either OSA or COPD.

Hypothesis: Elderly veterans (age 60 years) with moderate-to-severe OSA and concomitant moderate-to-severe COPD will have significantly increased cognitive deficits and daytime sleepiness compared with similar patients with OSA alone or COPD alone.

To study this aim the investigators will prospectively administer and compare the results of a battery of cognitive tests, and sleepiness and QoL questionnaires in elderly patients with OSA, COPD, and the Overlap Syndrome.

Aim B. To determine if treatment with PAP/NIPPV and/or supplemental oxygen compared to CPAP alone in elderly Veterans with OSA and concomitant moderate-to-severe COPD will improve cognitive function, sleepiness, and QoL.

Hypothesis: Therapy with PAP and supplemental oxygen will reverse neurocognitive deficits in one or more domains, reduce sleepiness, and improve QoL compared with CPAP alone in patients with moderate-to-severe OSA and concomitant moderate COPD. This aim will evaluate which specific deficits in neurocognitive function in patients with moderate-to-severe Overlap Syndrome are reversible and most sensitive to the effects of positive airway pressure (PAP) and oxygen vs CPAP alone.

To study this aim the investigators will randomize patients with the Overlap Syndrome to 3months of therapy with PAP and/or oxygen vs CPAP alone for 3 months and evaluate impact on neurocognitive function, sleepiness and quality of life before and after therapy.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Actual Study Start Date : August 17, 2016
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Positive airway pressure therapy
Control group patients will receive standard care with PAP- positive airway pressure.
Device: Positive airway pressure
CPAP will be applied as standard of care for diagnosis of moderate to severe OSA
Other Name: Standard of care control arm

Device: NIPPV and /or oxygen
supplemental oxygen will be applied to PAP/non-invasive positive pressure therapy
Other Name: Active intervention

No Intervention: COPD
The COPD control group will be patients with moderate-to-severe COPD alone per the GOLD criteria.
No Intervention: OSA and comorbid COPD
Eligible elderly (age >/=60yrs) Veterans with moderate to severe Overlap Syndrome.



Primary Outcome Measures :
  1. Neurocognitive function [ Time Frame: Change from baseline neurocognitive function at 3 months ]
    The neurocognitive test - Trails A test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  2. Sleepiness [ Time Frame: Change from baseline sleepiness at 3 months ]
    Epworth sleepiness scale score will be measured. This score is on a scale of 0-24, where a higher value indicates a worse outcome.

  3. Quality of life [ Time Frame: Change from baseline quality of life at 3 months ]
    Quality of Life (Qol) Questionnaires: QoL will be assessed using the Short-Form survey (SF-12). There are two subscale domain scores (Physical Health Composite Score-PCS and Mental Health Composite Score-MCS). These are on a scale of 0-100, where higher values indicate a better outcome.

  4. Neurocognitive test [ Time Frame: Change from baseline at 3 months ]
    The neurocognitive test - Trails B test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  5. Neurocognitive test [ Time Frame: Change from baseline at 3 months ]
    The neurocognitive test: PASAT (Paced Auditory Serial Addition Test) will be administered to evaluate vigilance and executive function. The PASAT is recorded as the total number of correct responses (from 0-60), or the percent of correct responses out of 60 (from 0-100), where a higher value is a better outcome.

  6. Neurocognitive test [ Time Frame: Change from baseline at 3 months ]
    The neurocognitive test: Stroop color-word interference test will be administered to evaluate executive function. This score is adjusted for age, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  7. Neurocognitive test [ Time Frame: Change from baseline at 3 months ]
    The neurocognitive DIGIT test will be administered to evaluate short-term and working memory. This score is adjusted for age. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  8. Neurocognitive test [ Time Frame: Change from baseline at 3 months ]
    The neurocognitive test: abbreviated Wechsler Abbreviated Scale of Intelligence (WASI) will be administered to evaluate verbal comprehension and working memory. This score is adjusted for age. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  9. Quality of life [ Time Frame: Change from baseline quality of life at 3 months ]
    Quality of Life (Qol) Questionnaires: Disease specific QoL will be assessed using the Functional Outcomes of Sleep Questionnaire FOSQ/(FOSQ)-10. There are 5 subscale domains of the FOSQ (General Productivity, Social Outcome, Activity Level, Vigilance, and Intimate Relationships and Sexual Activity). There all range from 0-20, where a higher value is a better outcome. The total FOSQ is the sum of these subscale domains and ranges from 0-100, where a higher value is a better outcome.

  10. Quality of life [ Time Frame: Change from baseline quality of life at 3 months ]
    Quality of Life (Qol) Questionnaires: Disease specific QoL will be assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ has three subscale domains (Symptoms, Activity, and Impacts), which range from 0-100, where a higher value indicates a worse outcome. The total SGRQ is the average of these subscale domains and is on a scale of 0-100, where a higher value is a worse outcome.


Secondary Outcome Measures :
  1. Dyspnea [ Time Frame: Change from baseline at 3 months ]
    6 minute walk test (6MWT): Participants are instructed to achieve maximal distance. There is no scale, but a larger value is a better outcome.

  2. Hours of nightly positive airway pressure (PAP) use/NIPPV use [ Time Frame: 90 days after start of therapy ]
    Collection of PAP adherence data from the smart card of the PAP machine or from online data.

  3. Hours of nightly oxygen use [ Time Frame: 3 months after start of therapy ]
    Adherence to supplemental oxygen (O2) will be determined by the total hours of nightly O2 use obtained from the O2 concentrator that is provided by the vendor.

  4. Borg scale [ Time Frame: Change from baseline at 3 months ]
    This measures the level of dyspnea during the 6 minute walk test. It is on a scale of 0-10, where a larger value is a worse outcome.

  5. Blood pressure [ Time Frame: At baseline ]
    Measure blood pressure at baseline visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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
  • Age 60 years
  • Male or female gender

Exclusion Criteria:

  • Mild COPD
  • Mild OSA
  • Overlap Syndrome with mild OSA plus mild COPD
  • Central sleep apnea defined as central apnea index >5 per hour
  • Already on daytime oxygen or nighttime CPAP, NIPPV, oral appliance
  • Current smokers
  • Pregnant women
  • Disorders of hypoventilation due to known neuromuscular or chest wall diseases**
  • Patients with significant restrictive lung disease on pulmonary function testing
  • Recent admission for any acute illness within the prior 4 months
  • Current psychiatric illness requiring sedating medications
  • Use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect alertness or daytime functioning for Aim 3/4
  • For Aim 3 and 4 only, existing depression as assessed by the PHQ (Patient Health Questionnaire)-9 (score >10)
  • History of learning disability
  • Inability to sign consent
  • Epworth sleepiness score 18 or a near-miss or prior automobile accident due to sleepiness within the past 12 months
  • Patients with unstable heart disease, decompensated heart failure, ejection fraction<45% or uncontrolled arrhythmias
  • Patients unable to use either a nasal or face mask (e.g., facial trauma)
  • Consumption of > 2 alcoholic beverages per day or past history of excessive alcohol use
  • Current use of illicit drugs
  • Patients who have problems with vision or dexterity and hence, cannot use CPAP/NIPPV
  • Life expectancy is less than 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703207


Contacts
Layout table for location contacts
Contact: Ruchi Rastogi, MSc (313) 576-1000 rrastogi@med.wayne.edu
Contact: Susmita Chowdhuri, MD (313) 576-1000 ext 63685 Susmita.Chowdhuri@va.gov

Locations
Layout table for location information
United States, Michigan
John D. Dingell VA Medical Center, Detroit, MI Recruiting
Detroit, Michigan, United States, 48201
Contact: Ruchi Rastogi, MSc    313-576-1000    rrastogi@med.wayne.edu   
Contact: Samuel P Mcvean    (313) 576-1000 ext 63106    Samuel.Mcvean@va.gov   
Principal Investigator: Susmita Chowdhuri, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Susmita Chowdhuri, MD John D. Dingell VA Medical Center, Detroit, MI

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02703207     History of Changes
Other Study ID Numbers: E2227-P
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
obstructive sleep apnea
COPD
Overlap syndrome
quality of life
neurocognitive function
sleepiness
elderly

Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Undifferentiated Connective Tissue Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases