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Device

Positive Airway Pressure Therapy for Overlap Syndrome

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 greater than or equal to 60 years

Be older than 18 years old

Must not have

Patient is actively suicidal due to depression, unstable mental health condition

Employed as a commercial driver or operating heavy machinery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and at 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at how well positive airway pressure therapy (a treatment for sleep apnea) works in veterans with both sleep apnea and COPD (a lung disease).

Who is the study for?

This trial is for veterans aged 60 or older with moderate-to-severe obstructive sleep apnea and chronic obstructive pulmonary disease, who have a significant history of smoking. They must not have used positive airway pressure before, be on stable COPD treatment, and not suffer from severe conditions that could affect cognitive function or safety.

What is being tested?

The study tests if using positive airway pressure therapy can improve life quality, sleep quality, and neurocognitive function in older veterans with Overlap Syndrome (both OSA and COPD). Participants will either receive standard care or the addition of this therapy.

What are the potential side effects?

While the document doesn't specify side effects, common ones for positive airway pressure therapy may include discomfort, nasal congestion, dry mouth or throat irritation due to airflow.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently experiencing severe depression or have unstable mental health.

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I work as a commercial driver or operate heavy machinery.

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I am currently receiving hospice care.

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I am unable to understand and agree to the study's procedures and risks.

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I use oxygen therapy for more than 12 hours a day.

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I have used a PAP machine or oral appliance for treatment.

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I have narcolepsy and need stimulant medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 3 and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at 3 and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 3 and 6 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 DIGIT

Neurocognitive function HVLT-R

Neurocognitive function PASAT

+10 more

Secondary study objectives

Blood CO2 or bicarbonate level

Fatigue severity

Hours of nightly positive airway pressure (PAP) use

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Conservative care (control arm)Experimental Treatment1 Intervention

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.

Group II: PAP therapy armActive Control1 Intervention

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

0 / 8Eligibility criteria met