Effects of an Air Purifying Device (PureNight) on Sleep Quality in Obstructive Lung Disease
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|ClinicalTrials.gov Identifier: NCT01772342|
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : January 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Other: HEPA filtration Other: SHAM||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Effects of a Novel Purifying Device (PureNight) on Sleep Quality in Chronic Obstructive Pulmonary Disease|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Experimental: Nocturnal Air Purification
Other: HEPA filtration
Night time air purification with the PureNight air purification system with the HEPA filter in place
Night time air purification with the PureNight air purification system with the HEPA filter removed
- Change in Sleep Fragmentation Index from baseline [ Time Frame: Measurements are averaged during the first week of the study (baseline) and then during week 2 and week 4 when subjects slept with the air purifier with either HEPA or SHAM filtration ]Data is obtained from a wrist-worn motion sensor that detects body movement. From these data, the number of disruptions during sleep can be calculated.
- Change in Sleep-related quality of life from baseline [ Time Frame: Measurements are taken at the start of the study (baseline) and then at the end of week 2 and week 4 when subjects slept with the air purifier with either HEPA or SHAM filtration ]Total score of Pittsburgh Sleep Quality Index, which is a health-related quality of sleep questionnaire that measures perception of sleep quality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772342
|Principal Investigator:||Miriam D Cohen||VA, NYHH|