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

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: NCT04179981
Recruitment Status : Not yet recruiting
First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndrome Obstructive Sleep Apnea COPD Overlap Syndrome Quality of Life Neurocognitive Function Sleepiness Elderly Positive Airway Pressure Device: Positive airway pressure Other: Conservative care (control arm) Not Applicable

Detailed Description:

There are no studies regarding the impact of PAP therapy on sleep disturbance, cognitive function and quality of life in patients with OVS. The investigators' rationale is that in patients with moderate-severe OVS, PAP therapy will effectively alleviate sleepiness, sleep disturbances and cognitive deficits, and, thereby, improve QoL. 'PAP' includes either continuous positive airway pressure (CPAP) or noninvasive positive airway pressure ventilation (NIPPV).

Objectives:

Specifically, the investigators will study the effectiveness of PAP therapy vs. conservative care in reducing daytime sleepiness and in improving sleep quality and QoL in older Veterans with OVS.

The investigators will also explore whether CPAP is non-inferior to noninvasive positive airway pressure ventilation (NIPPV) in reducing daytime sleepiness, sleep disturbances and neurocognitive dysfunction, and in improving QoL in older Veterans with OVS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparing outcomes in patients with OVS after randomization to PAP therapy vs. conservative care in a parallel group fashion
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : March 2, 2020
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Conservative care (control arm)
Eligible OVS patients will receive conservative care/usual care with education about sleep apnea and sleep hygiene via handouts and video instructions. This is the control arm.
Other: Conservative care (control arm)
Eligible OVS patients will receive conservative care/usual care with education about sleep apnea and sleep hygiene via handouts and video instructions. This is the control arm.

Active Comparator: PAP therapy arm
PAP Therapy will be provided to eligible patients with OVS. This is the active therapy arm.
Device: Positive airway pressure
Positive airway pressure therapy. OVS patients randomized to PAP therapy arm will be titrated to optimal PAP therapy per standard protocol and assigned to use PAP therapy.




Primary Outcome Measures :
  1. Neurocognitive function Trails A and Trails B [ Time Frame: Change from baseline at 3 and 6 months ]
    Trails A and 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.

  2. Neurocognitive function PASAT [ Time Frame: Change from baseline at 3 and 6 months ]
    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.

  3. Neurocognitive function Stroop color-word interference [ Time Frame: Change from baseline at 3 and 6 months ]
    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.

  4. Neurocognitive function DIGIT [ Time Frame: Change from baseline at 3 and 6 months ]
    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.

  5. Neurocognitive function WASI [ Time Frame: Change from baseline at 3 and 6 months ]
    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.

  6. Neurocognitive function WMS [ Time Frame: Change from baseline at 3 and 6 months ]
    Wechsler Memory test (WMS) will be administered to measure Verbal comprehension, and working and visual memory. Scored on a Standard scale of 100 +/- 15, where a higher score is a better outcome.

  7. Neurocognitive function PVT [ Time Frame: Change from baseline at 3 and 6 months ]
    Psychomotor Vigilance Test (PVT) will be administered to measure Alertness and vigilance, in terms of number of lapses and reaction time. The performance score ranges from 0-100, where a higher value is a better outcome.

  8. Neurocognitive function HVLT-R [ Time Frame: Change from baseline at 3 and 6 months ]
    Hopkins Verbal Learning Test - Revised (HVLT-R) will be administered to evaluate Verbal learning and memory. Scored on a Standard scale of 100 +/- 15, where a higher score is a better outcome.

  9. Sleepiness ESS [ Time Frame: Change from baseline at 3 and 6 months ]
    Epworth sleepiness scale (ESS) score will be measured. This score is on a scale of 0-24, where a higher value indicates greater degree of sleepiness.

  10. Sleepiness PSQI [ Time Frame: Change from baseline at 3 and 6 months ]
    Pittsburgh Sleep Quality Index (PSQI) is a detailed assessment of subject sleep quality over the most recent month by considering seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score to assess sleep quality on a scale of "poor" to "good".

  11. Quality of life SF-36v2 [ Time Frame: Change from baseline at 3 and 6 months ]
    QoL will be assessed using the survey SF-36v2 Health survey. Thirty-five of the SF-36v2 items are used to measure eight domains of health-related quality of life. These are on a scale of 0-100, where higher values indicate a better outcome.

  12. Quality of life FOSQ [ Time Frame: Change from baseline at 3 and 6 months ]
    Disease specific QoL will be assessed using the Functional Outcomes of Sleep Questionnaire FOSQ/(FOSQ). 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.

  13. Quality of life SGRQ [ Time Frame: Change from baseline at 3 and 6 months ]
    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. Hours of nightly positive airway pressure (PAP) use [ Time Frame: Change from baseline at 3 and 6 months ]
    Collection of PAP adherence data from the smart card of the PAP machine or from online data.

  2. Patient preference for type of PAP (PAP arm) [ Time Frame: at 3 and 6 months ]
    A visual analog scale to determine preference to CPAP vs NIPPV therapy. A scores will range from -10 to +10, where a higher score is better.

  3. Fatigue severity [ Time Frame: Change from baseline at 3 and 6 months ]
    Fatigue Severity Scale (FSS): FSS measures how fatigue affects motivation, exercise, physical functioning, carrying out duties, interfering with work, family, or social life. Where a higher value is a worse outcome.

  4. Sleep-dependent memory [ Time Frame: At baseline and at 3 months ]
    In a subgroup of patients, the investigators will perform Word-pair test and PVT before and after sleep period, this is an exploratory measure.

  5. Blood CO2 or bicarbonate level [ Time Frame: At baseline and at 6 months ]
    Test is being done to evaluate for presence or absence of hypercapnia



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Male or female gender
  • Age greater than or equal to 60 years
  • Stable treatment regimen for COPD

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% of AHI
  • 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 as these 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 automobile accident 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

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): NCT04179981


Contacts
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Contact: Susmita Chowdhuri, MD (313) 576-1000 ext 63685 Susmita.Chowdhuri@va.gov

Locations
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United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
Contact: Afifa Uzzaman, MD    734-769-7100    afifa@med.umich.edu   
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, United States, 48201
Contact: Ruchi Rastogi, MSc    313-576-1000    ruchi.rastogi@va.gov   
Contact: Edi Levi, MD    (313) 576-4451    edi.levi@va.gov   
Principal Investigator: Susmita Chowdhuri, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Susmita Chowdhuri, MD John D. Dingell VA Medical Center, Detroit, MI

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04179981    
Other Study ID Numbers: E3124-R
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
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:
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Apnea
Sleep Apnea Syndromes
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Sleep Apnea, Obstructive
Undifferentiated Connective Tissue Diseases
Syndrome
Sleepiness
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
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