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Sleep Apnea Treatments for Sleep Apnea with COPD

N/A

Recruiting

Led By Susmita Chowdhuri, MD

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at 3 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline quality of life at 3 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neurocognitive function

Neurocognitive test

Quality of life

+1 more

Secondary outcome measures

Blood pressure

Borg scale

Dyspnea

+2 more

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,305,076 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the subject pool for this experiment restricted to those aged 55 and above?

"This clinical trial will consider patients aged between 60 and 89 years old."

Answered by AI

How many participants are currently involved in this investigation?

"Affirmative. According to the clinicaltrials.gov information, this study is actively seeking patients that meet its inclusion criteria. The trial was originally posted on August 17th 2016 and has been updated as recently as September 13th 2022; it requires 108 people from one medical centre for participation."

Answered by AI

Who is eligible to be part of this experiment?

"This clinical trial seeks 108 participants, aged between 60 and 89 years old, who have obstructive sleep apnea (OSA). Additionally, patients must qualify by meeting the ICSD-3 criteria with moderate to severe OSA indicated by an AHI of 15 or higher; having COPD status at a Global Obstructive Lung Disease grade 2 or 3 level evidenced by FEV1/FVC ratio below 70% and FEV1 greater than 30%, but less than 80%; plus a substantial past history of smoking (at least 10 pack-years) regardless of gender."

Answered by AI

What are the desired results of this trial?

"This trial will assess the efficacy of a potential treatment over 3 months by measuring changes in quality of life and administering neurocognitive tests. Additionally, secondary outcomes such as adherence to supplemental oxygen use, blood pressure levels, and 6-minute walk test results are also being evaluated."

Answered by AI

Is recruitment currently underway for this trial?

"Affirmative. According to the clinicaltrials.gov website, this medical trial is currently recruiting volunteers and began doing so on August 17th 2016; it was last updated 13 September 2022. The study requires 108 participants from a single site.."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2016. "Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02703207.

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