Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Apnea
COPD
Elderly
Lung Diseases, Obstructive
Neurocognitive Function
Obstructive Sleep Apnea
Overlap Syndrome
Positive Airway Pressure
Pulmonary Disease, Chronic Obstructive
Quality of Life
Sleep Apnea Syndrome
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleepiness
Syndrome
Undifferentiated Connective Tissue Diseases

Clinical Trial Details

NCT number	NCT04179981
Study type	Interventional
Source	VA Office of Research and Development
Contact	Ruchi Rastogi, MSc
Phone	(313) 576-1000
Email	ruchi.rastogi@va.gov
Status	Recruiting
Phase	N/A
Start date	December 1, 2020
Completion date	December 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms