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

January 23, 2013 updated by: Miriam D Cohen, VA New York Harbor Healthcare System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA New York Harbor Healthcare System

Investigators

  • Principal Investigator: Miriam D Cohen, VA, NYHH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (Estimate)

January 21, 2013

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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