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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Positive airway pressure
  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.
• Другое Conservative care (control arm)
  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.

Первичные конечные точки

• Neurocognitive function Trails A and Trails B [Срок оценки: Change from baseline at 3 and 6 months]
• Neurocognitive function PASAT [Срок оценки: Change from baseline at 3 and 6 months]
• Neurocognitive function Stroop color-word interference [Срок оценки: Change from baseline at 3 and 6 months]
• Neurocognitive function DIGIT [Срок оценки: Change from baseline at 3 and 6 months]
• Neurocognitive function WASI [Срок оценки: Change from baseline at 3 and 6 months]
• Neurocognitive function WMS [Срок оценки: Change from baseline at 3 and 6 months]
• Neurocognitive function PVT [Срок оценки: Change from baseline at 3 and 6 months]
• Neurocognitive function HVLT-R [Срок оценки: Change from baseline at 3 and 6 months]
• Sleepiness ESS [Срок оценки: Change from baseline at 3 and 6 months]
• Sleep quality PSQI [Срок оценки: Change from baseline at 3 and 6 months]

Вторичные конечные точки (5)

• Hours of nightly positive airway pressure (PAP) use [Срок оценки: Change from baseline at 3 and 6 months]
• Patient preferance for type of PAP (PAP arm) [Срок оценки: at 3 and 6 months]
• Fatigue severity [Срок оценки: Change from baseline at 3 and 6 months]
• Sleep-dependent memory [Срок оценки: At baseline and at 3 months]
• Blood CO2 or bicarbonate level [Срок оценки: At baseline and at 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• John D. Dingell VA Medical Center, Detroit, MI — Detroit

Идентификаторы

NCT: NCT04179981 · E3124-R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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