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

NCT01772342 | Completed

• 1 other identifier: 01056
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Sleep Fragmentation; Quality of Life; Air Filters

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Sleep-related quality of life from baseline

  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

Study Arms (1)

Nocturnal Air Purification

EXPERIMENTAL

* Hepa Filtration with PureNight * SHAM with PureNight

Other: HEPA filtration; Other: SHAM

Interventions

HEPA filtration OTHER

Night time air purification with the PureNight air purification system with the HEPA filter in place

Nocturnal Air Purification

SHAM OTHER

Night time air purification with the PureNight air purification system with the HEPA filter removed

Nocturnal Air Purification

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA New York Harbor Healthcare System: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Deprivation

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Officials

• Miriam D Cohen

  VA, NYHH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Practitioner

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 21, 2013
• Study Start: March 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 24, 2013

Record last verified: 2013-01