Effects of an Air Purifying Device (PureNight) on Sleep Quality in Obstructive Lung Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HEPA filtration
SHAM
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Sleep Fragmentation, Quality of Life, Air Filters
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nocturnal Air Purification
Arm Description
Hepa Filtration with PureNight SHAM with PureNight
Outcomes
Primary Outcome Measures
Change in Sleep Fragmentation Index from baseline
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.
Secondary Outcome Measures
Change in Sleep-related quality of life from baseline
Total score of Pittsburgh Sleep Quality Index, which is a health-related quality of sleep questionnaire that measures perception of sleep quality
Full Information
NCT ID
NCT01772342
First Posted
January 16, 2013
Last Updated
January 23, 2013
Sponsor
VA New York Harbor Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT01772342
Brief Title
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
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA New York Harbor Healthcare System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Sleep Fragmentation, Quality of Life, Air Filters
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nocturnal Air Purification
Arm Type
Experimental
Arm Description
Hepa Filtration with PureNight
SHAM with PureNight
Intervention Type
Other
Intervention Name(s)
HEPA filtration
Intervention Description
Night time air purification with the PureNight air purification system with the HEPA filter in place
Intervention Type
Other
Intervention Name(s)
SHAM
Intervention Description
Night time air purification with the PureNight air purification system with the HEPA filter removed
Primary Outcome Measure Information:
Title
Change in Sleep Fragmentation Index from baseline
Description
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.
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
Secondary Outcome Measure Information:
Title
Change in Sleep-related quality of life from baseline
Description
Total score of Pittsburgh Sleep Quality Index, which is a health-related quality of sleep questionnaire that measures perception of sleep quality
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam D Cohen
Organizational Affiliation
VA, NYHH
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effects of an Air Purifying Device (PureNight) on Sleep Quality in Obstructive Lung Disease
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