Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years to 80 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
VA New York Harbor Healthcare System |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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 | No |
Secondary | 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 | 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 | No |
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