Clinical trial NCT01772342: Effects of an Air Purifying Device (PureNight) on Sleep Quality in Obstructive Lung Disease
Official title: Effects of a Novel Purifying Device (PureNight) on Sleep Quality in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Sleep Fragmentation
Quality of Life
Air Filters
Lead sponsor: VA New York Harbor Healthcare System
Sponsor class: FED
First posted: 2013-01-21
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD, chronic airway obstruction, chronic bronchitis or emphysema or \> 15 pack year history of tobacco use
* Secondary diagnosis of extrinsic asthma or allergic rhinitis or \> 200 ml FEV1 response to bronchodilators documented on pulmonary function testing
* Positive score on sleep quality questionnaire

Exclusion Criteria:

* Unable or unwilling to give informed consent
* Impairment of cognition or communication
* History of drug or alcohol treatment within the past 6 months
* Recent acute medical event that would suggest a contraindication to participate at the scheduled time
* Treatment with antibiotics or steroids for COPD exacerbation within past 6 weeks
* Baseline of three or more episodes of nocturia per night
* On home oxygen or non-invasive positive pressure breathing
* Diagnosis of obstructive sleep apnea or body mass index \> 35
* Primary sleep disorder, such as insomnia

Primary outcomes:
measure: Change in Sleep Fragmentation Index from baseline
timeFrame: 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
Secondary outcomes:
measure: Change in Sleep-related quality of life from baseline
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: VA, NYHH
name: Miriam D Cohen
role: PRINCIPAL_INVESTIGATOR
References: