Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effects of a Novel Purifying Device (PureNight) on Sleep Quality in Chronic Obstructive Pulmonary Disease
Many individuals with chronic lung disease have night time symptoms that disrupt their sleep. The purpose of this study is to determine the effects of an air purifying device (PureNight, Halo Innovations, Minneapolis, MN) on sleep disruptions measured by a "sleep watch" (actigraph) and individual perception of sleep quality.
Objective There are many detrimental effects of obstructive airway disease. One of the
hallmark effects is poor sleep quality. Due to the association of air pollutants with
worsening respiratory symptoms, a logical intervention to improve sleep quality may be air
filtration. A novel air filtration system, the PureNight SystemTM, which delivers
pre-filtered air around the head of a sleeping person, may offer a solution to decrease
exposure to noxious triggers during time spent sleeping and improve sleep quality.
One method to measure sleep quality is to use 24-hour actigraphy. The actigraph is a small,
wrist-worn device that contains a pizo-electric bender element, or accelerometer, that
measures wrist movement. Algorithms interpret the movement on an epoch-by-epoch basis and
identify sleep/wake states and circadian rhythms from activity counts.
Study Design We propose to study the effect of the Pure Night TM air filtration system on a
cohort of patients with chronic obstructive airway disease with self-reported poor sleep
quality due to nocturnal respiratory symptoms. We hypothesized that patients using the Pure
Night TM system would have fewer nocturnal awakenings and a consolidation of sleep time
measured by actigraphy and better sleep quality measured by quality of sleep questionnaires
than when not using the device. In a cross-over randomized clinical trial, baseline
measurements were compared to treatment with the PureNight TM device and with "sham"
filtration. Sleep variables including data on circadian rhythms were compared using a
within-subject design between test conditions.
Methodology Each subject underwent baseline actigraphy over 7 days followed by two seven day
treatment arms with a 7-day wash-out period between treatment arms. Subject slept with the
PureNight during each arm of the study. The systems used in each arm of the study were
identical except one arm had a sham filter replacing the HEPA filter of the PureNight TM
system in random order. Participants completed the Pittsburgh Sleep Quality Index at the
start of the study and at the end of each treatment phase. Objective estimates of sleep were
calculated from the actigraphy recordings using the device's proprietary software.
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Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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