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Device

Sleep Apnea Treatments for Sleep Apnea with COPD

N/A
Recruiting
Led By Susmita Chowdhuri, MD MS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 60 years
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
Must not have
Current psychiatric illness requiring sedating medications
Inability to sign consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial seeks to study whether two common diseases among elderly Veterans, obstructive sleep apnea and COPD, have an effect on cognitive function when they exist together. Additionally, the trial will study whether treating OSA with positive airway pressure and COPD with supplemental oxygen will improve cognitive function and quality of life.

Who is the study for?
This trial is for elderly veterans aged 60 or older with moderate-to-severe obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD). Participants must have a significant history of smoking but cannot be current smokers, not on oxygen or CPAP therapy, and without central sleep apnea, recent acute illness, psychiatric illnesses requiring sedation, unstable heart conditions, or life expectancy under six months.
What is being tested?
The study aims to see if positive airway pressure (PAP) treatments alone or combined with supplemental oxygen can improve cognitive function and quality of life in elderly veterans with 'Overlap Syndrome'—a combination of OSA and COPD. The effectiveness will be compared between those receiving just PAP versus PAP plus additional oxygen.
What are the potential side effects?
While the description doesn't specify side effects directly related to the interventions being tested (PAP therapy), common issues may include discomfort from mask use, dry nose/throat, nasal congestion, headaches, bloating and difficulty falling asleep.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years old or older.
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I have moderate-to-severe COPD, a history of significant smoking, and recent lung function tests.
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I have moderate-to-severe sleep apnea with an AHI of 15 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medication for a psychiatric condition that makes me sleepy.
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I am unable to give consent by myself.
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I do not have severe heart problems like uncontrolled irregular heartbeats or very weak heart pumping.
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I have not been admitted to the hospital for a sudden illness in the last 4 months.
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I have breathing issues due to muscle or chest wall diseases.
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I have severe lung disease confirmed by tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline quality of life at 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline quality of life at 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neurocognitive function
Neurocognitive test
Quality of life
+1 more
Secondary study objectives
Blood pressure
Borg scale
Dyspnea
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Positive airway pressure therapyActive Control2 Interventions
Control group patients will receive standard care with PAP- positive airway pressure.
Group II: COPDActive Control1 Intervention
The COPD control group will be patients with moderate-to-severe COPD alone per the GOLD criteria.
Group III: OSA and comorbid COPDActive Control1 Intervention
Eligible elderly (age \>/=60yrs) Veterans with moderate to severe Overlap Syndrome.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,675 Total Patients Enrolled
Susmita Chowdhuri, MD MSPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI
3 Previous Clinical Trials
500 Total Patients Enrolled
Susmita Chowdhuri, MDPrincipal InvestigatorJohn D. Dingell VA Medical Center, Detroit, MI
4 Previous Clinical Trials
592 Total Patients Enrolled

Media Library

NIPPV and /or oxygen (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02703207 — N/A
Obstructive Sleep Apnea Research Study Groups: Positive airway pressure therapy, COPD, OSA and comorbid COPD
Obstructive Sleep Apnea Clinical Trial 2023: NIPPV and /or oxygen Highlights & Side Effects. Trial Name: NCT02703207 — N/A
NIPPV and /or oxygen (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02703207 — N/A
~10 spots leftby Sep 2025
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