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Effects of an Air Purifying Device (PureNight) on Sleep Quality in Obstructive Lung Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01772342
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : January 24, 2013
Information provided by (Responsible Party):
Miriam D Cohen, VA New York Harbor Healthcare System

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: HEPA filtration Other: SHAM Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arm Intervention/treatment
Experimental: Nocturnal Air Purification
  • Hepa Filtration with PureNight
  • SHAM with PureNight
Other: HEPA filtration
Night time air purification with the PureNight air purification system with the HEPA filter in place

Other: SHAM
Night time air purification with the PureNight air purification system with the HEPA filter removed

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01772342

Sponsors and Collaborators
VA New York Harbor Healthcare System
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Principal Investigator: Miriam D Cohen VA, NYHH

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Responsible Party: Miriam D Cohen, Nurse Practitioner, VA New York Harbor Healthcare System Identifier: NCT01772342    
Other Study ID Numbers: 01056
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013
Keywords provided by Miriam D Cohen, VA New York Harbor Healthcare System:
Sleep Fragmentation
Quality of Life
Air Filters
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases