Chronic Obstructive Pulmonary DiseaseNCT01772342
Effects of an Air Purifying Device (PureNight) on Sleep Quality in Obstructive Lung Disease
A study testing HEPA filtration in people with Chronic Obstructive Pulmonary Disease, run by VA New York Harbor Healthcare System.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- HEPA filtration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- HEPA filtration, SHAM
- Keywords
- Sleep Fragmentation, Quality of Life, Air Filters
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPA filtrationOther
Night time air purification with the PureNight air purification system with the HEPA filter in place
SHAMOther
Night time air purification with the PureNight air purification system with the HEPA filter removed
| Study group | Role | What they receive |
|---|---|---|
| Nocturnal Air Purification | Experimental | * Hepa Filtration with PureNight
* SHAM with PureNight Receives: Other: HEPA filtration; Other: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Total score of Pittsburgh Sleep Quality Index, which is a health-related quality of sleep questionnaire that measures perception of sleep quality
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startMar 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA New York Harbor Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Miriam D Cohen, VA New York Harbor Healthcare System
- Investigators
- Miriam D Cohen, Principal investigator, VA, NYHH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772342
- Sponsor's protocol ID
- 01056
- Status last verified
- Jan 2013
- First submitted
- 16 Jan 2013
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Novel Purifying Device (PureNight) on Sleep Quality in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01772342
- Acronym / sponsor ID
- 01056
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Sleep Fragmentation, Quality of Life, Air Filters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- VA New York Harbor Healthcare SystemUS federal agency
- Study start
- Mar 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nocturnal Air Purification | Experimental | Other: HEPA filtration, Other: SHAM* Hepa Filtration with PureNight * SHAM with PureNight |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEPA filtrationNight time air purification with the PureNight air purification system with the HEPA filter in place | Other | Nocturnal Air Purification |
| SHAMNight time air purification with the PureNight air purification system with the HEPA filter removed | Other | Nocturnal Air Purification |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam D Cohen principal investigator
VA, NYHH
Questions about this trial
What is this clinical trial studying?
A study testing HEPA filtration in people with Chronic Obstructive Pulmonary Disease, run by VA New York Harbor Healthcare System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.