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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)

Primary Purpose

Sleep Apnea Syndrome, Obstructive Sleep Apnea, COPD

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive airway pressure
Conservative care (control arm)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndrome focused on measuring 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

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Ann Arbor Healthcare System, Ann Arbor, MI
  • John D. Dingell VA Medical Center, Detroit, MIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Conservative care (control arm)

PAP therapy arm

Arm Description

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.

PAP Therapy will be provided to eligible patients with OVS. This is the active therapy arm.

Outcomes

Primary Outcome Measures

Neurocognitive function Trails A and Trails B
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.
Neurocognitive function PASAT
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.
Neurocognitive function Stroop color-word interference
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.
Neurocognitive function DIGIT
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.
Neurocognitive function WASI
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.
Neurocognitive function WMS
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.
Neurocognitive function PVT
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.
Neurocognitive function HVLT-R
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.
Sleepiness ESS
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.
Sleep quality PSQI
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".
Quality of life SF-36v2
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.
Quality of life FOSQ
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.
Quality of life SGRQ
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

Hours of nightly positive airway pressure (PAP) use
Collection of PAP adherence data from the smart card of the PAP machine or from online data.
Patient preferance for type of PAP (PAP arm)
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.
Fatigue severity
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.
Sleep-dependent memory
In a subgroup of patients, the investigators will perform Word-pair test and PVT before and after sleep period, this is an exploratory measure.
Blood CO2 or bicarbonate level
Test is being done to evaluate for presence or absence of hypercapnia

Full Information

First Posted
November 25, 2019
Last Updated
January 12, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04179981
Brief 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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 29, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome, Obstructive Sleep Apnea, COPD, Overlap Syndrome, Quality of Life, Neurocognitive Function, Sleepiness, Elderly, Positive Airway Pressure
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparing outcomes in patients with OVS after randomization to PAP therapy vs. conservative care in a parallel group fashion
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conservative care (control arm)
Arm Type
Other
Arm Description
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.
Arm Title
PAP therapy arm
Arm Type
Active Comparator
Arm Description
PAP Therapy will be provided to eligible patients with OVS. This is the active therapy arm.
Intervention Type
Device
Intervention Name(s)
Positive airway pressure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conservative care (control arm)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neurocognitive function Trails A and Trails B
Description
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.
Time Frame
Change from baseline at 3 and 6 months
Title
Neurocognitive function PASAT
Description
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.
Time Frame
Change from baseline at 3 and 6 months
Title
Neurocognitive function Stroop color-word interference
Description
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.
Time Frame
Change from baseline at 3 and 6 months
Title
Neurocognitive function DIGIT
Description
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.
Time Frame
Change from baseline at 3 and 6 months
Title
Neurocognitive function WASI
Description
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.
Time Frame
Change from baseline at 3 and 6 months
Title
Neurocognitive function WMS
Description
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.
Time Frame
Change from baseline at 3 and 6 months
Title
Neurocognitive function PVT
Description
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.
Time Frame
Change from baseline at 3 and 6 months
Title
Neurocognitive function HVLT-R
Description
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.
Time Frame
Change from baseline at 3 and 6 months
Title
Sleepiness ESS
Description
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.
Time Frame
Change from baseline at 3 and 6 months
Title
Sleep quality PSQI
Description
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".
Time Frame
Change from baseline at 3 and 6 months
Title
Quality of life SF-36v2
Description
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.
Time Frame
Change from baseline at 3 and 6 months
Title
Quality of life FOSQ
Description
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.
Time Frame
Change from baseline at 3 and 6 months
Title
Quality of life SGRQ
Description
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.
Time Frame
Change from baseline at 3 and 6 months
Secondary Outcome Measure Information:
Title
Hours of nightly positive airway pressure (PAP) use
Description
Collection of PAP adherence data from the smart card of the PAP machine or from online data.
Time Frame
Change from baseline at 3 and 6 months
Title
Patient preferance for type of PAP (PAP arm)
Description
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.
Time Frame
at 3 and 6 months
Title
Fatigue severity
Description
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.
Time Frame
Change from baseline at 3 and 6 months
Title
Sleep-dependent memory
Description
In a subgroup of patients, the investigators will perform Word-pair test and PVT before and after sleep period, this is an exploratory measure.
Time Frame
At baseline and at 3 months
Title
Blood CO2 or bicarbonate level
Description
Test is being done to evaluate for presence or absence of hypercapnia
Time Frame
At baseline and at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susmita Chowdhuri, MD
Phone
(313) 576-1000
Ext
63685
Email
Susmita.Chowdhuri@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susmita Chowdhuri, MD
Organizational Affiliation
John D. Dingell VA Medical Center, Detroit, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Enrolling by invitation
Facility Name
John D. Dingell VA Medical Center, Detroit, MI
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruchi Rastogi, MSc
Phone
313-576-1000
Email
ruchi.rastogi@va.gov
First Name & Middle Initial & Last Name & Degree
Edi Levi, MD
Phone
(313) 576-4451
Email
edi.levi@va.gov
First Name & Middle Initial & Last Name & Degree
Susmita Chowdhuri, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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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)

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