COPDNCT01764165
Pathogenesis and Outcomes of Sleep Disordered Breathing in Chronic Obstructive Pulmonary Disease (COPD)
A study testing Oxygen and High flow of room air in people with COPD, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being conducted to examine the effects of nasal insufflation of warm and humidified air through a small nasal cannula on sleep, breathing pulmonary function, and daytime exercise capability. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Oxygen and High flow of room air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Oct 2016
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consenting adults over the age of 21
- BMI < 40 kg/m2
Who cannot join
- Diagnosed with sleep apnea (apnea and hypopneas of >10 events/hr).
- A sleep efficiency of <30%, or a prior diagnosis of disorders that impair sleep architecture.
- Unstable cardiovascular disease (decompensated heart failure, myocardial infarction within the past 3 months, revascularization procedure within the past 3 months, unstable arrhythmias, uncontrolled hypertension (BP > 190/110)).
- Severe renal insufficiency requiring dialysis.
- Liver cirrhosis.
- A recent acute illness in a 6 weeks period prior to the sleep studies.
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- We will exclude subjects with severe daytime hypoxemia (Oxyhemoglobin saturation (SaO2) <80% or partial pressure of oxygen (PaO2) <55 mmHg at rest).
- Chronic use of sedatives or respiratory depressants that would affect sleep quality (e.g., benzodiazepines or other hypnotics or narcotics).
- Pregnancy.
- Tracheostomy or other significant oropharyngeal or nasopharyngeal surgery, in the last 6 months.
- Narcolepsy and other neurological disorders such as Parkinson's Disease.
- Severe hepatic insufficiency.
- Bleeding disorders or Coumadin use.
- Allergy to lidocaine or benzocaine.
- Language/dementia/psychiatric issues - the participant must be able to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pathogenesis and Outcomes of Sleep Disordered Breathing in COPD
This research is being conducted to examine the effects of nasal insufflation of warm and humidified air through a small nasal cannula on sleep, breathing pulmonary function, and daytime exercise capability.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is associated with significant morbidity including substantial daytime fatigue exertional intolerance and ventilatory impairment, which hits a nadir in the morning. Nocturnal disturbances in sleep and breathing are common in COPD, although the impact of these disturbances on COPD morbidity remains largely unknown. The hypothesis is that COPD induces specific sleep and breathing disturbances that remain a substantial source of morbidity in this disorder.
Current therapy for treating nocturnal disturbances in sleep and breathing in COPD including nocturnal oxygen has failed to improve morning fatigue and pulmonary function. This study promises to significantly alter our approach to the diagnosis and management of sleep disordered breathing in COPD.
- Conditions
- COPD
- Being tested
- Oxygen, High flow of room air
- Keywords
- COPD, Sleep, Supplemental oxygen, Breathing mechanics, nasal insufflation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenOther
Also called supplemental oxygen, nocturnal oxygen
oxygen at a rate of 2 L/min will be delivered through a small nasal cannula throughout sleep.
High flow of room airOther
Also called TNI: Transnasal insufflation, Open CPAP, Optiflow
Warm and humidified air at rates of 20 L/min will be delivered through a small nasal cannula throughout sleep
| Study group | Role | What they receive |
|---|---|---|
| oxygen | Active comparator | nocturnal oxygen of 2 L/min Receives: Other: Oxygen |
| High Flow of room air | Experimental | Warm and humidified air at a rate of 20 L/min through a small nasal cannula (similar to oxygen cannula) Receives: Other: High flow of room air |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evening to morning differences in expiratory airflow obstruction (FEV1/FVC)
Lung function declines over the course of the night. We hypothesize that delivering warm and humidified air at a rate of 20 L/min over the entire night improves morning FEV1 compared to oxygen.
Measured: 4 years
Secondary outcomes (2)
The percent rate of inspiratory flow limitation.
Patients with COPD often exhibit inspiratory air flow limitation during sleep. We hypothesize that delivering warm and humidified air at a rate of 20 L/min reduces the degree of inspiratory air flow limitation compared to oxygen.
Measured: 4 Years
Effect of High flow nasal insufflation of air on exercise capacity (6 minute walk test).
Patients with COPD have impaired exercise tolerance in the morning. We hypothesize that delivering warm and humidified air at a rate of 20 L/min over the entire night extends morning 6 minute walk length.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startAug 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Hartmut Schneider, Johns Hopkins University
- Investigators
- Hartmut Schneider, M.D., Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764165
- Sponsor's protocol ID
- R01HL105546-01
- Other IDs
- NA_00040333
- Status last verified
- Oct 2016
- First submitted
- 16 Jul 2010
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schneider H, Krishnan V, Pichard LE, Patil SP, Smith PL, Schwartz AR. Inspiratory duty cycle responses to flow limitation predict nocturnal hypoventilation. Eur Respir J. 2009 May;33(5):1068-76. doi: 10.1183/09031936.00063008. Epub 2009 Jan 7.
PubMed 19129290
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenesis and Outcomes of Sleep Disordered Breathing in COPD
- ClinicalTrials.gov ID
- NCT01764165
- Acronym / sponsor ID
- R01HL105546-01
- Conditions
- COPD
- Keywords
- COPD, Sleep, Supplemental oxygen, Breathing mechanics, nasal insufflation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 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.
This research is being conducted to examine the effects of nasal insufflation of warm and humidified air through a small nasal cannula on sleep, breathing pulmonary function, and daytime exercise capability.
Detailed description
Chronic obstructive pulmonary disease (COPD) is associated with significant morbidity including substantial daytime fatigue exertional intolerance and ventilatory impairment, which hits a nadir in the morning. Nocturnal disturbances in sleep and breathing are common in COPD, although the impact of these disturbances on COPD morbidity remains largely unknown. The hypothesis is that COPD induces specific sleep and breathing disturbances that remain a substantial source of morbidity in this disorder.
Current therapy for treating nocturnal disturbances in sleep and breathing in COPD including nocturnal oxygen has failed to improve morning fatigue and pulmonary function. This study promises to significantly alter our approach to the diagnosis and management of sleep disordered breathing in COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxygen | Active comparator | Other: Oxygennocturnal oxygen of 2 L/min |
| High Flow of room air | Experimental | Other: High flow of room airWarm and humidified air at a rate of 20 L/min through a small nasal cannula (similar to oxygen cannula) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consenting adults over the age of 21
- BMI < 40 kg/m2
Key exclusion criteria (15 listed)
- Diagnosed with sleep apnea (apnea and hypopneas of >10 events/hr).
- A sleep efficiency of <30%, or a prior diagnosis of disorders that impair sleep architecture.
- Unstable cardiovascular disease (decompensated heart failure, myocardial infarction within the past 3 months, revascularization procedure within the past 3 months, unstable arrhythmias, uncontrolled hypertension (BP > 190/110)).
- Severe renal insufficiency requiring dialysis.
- Liver cirrhosis.
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 |
|---|---|---|
| OxygenAlso: supplemental oxygen, nocturnal oxygenoxygen at a rate of 2 L/min will be delivered through a small nasal cannula throughout sleep. | Other | oxygen |
| High flow of room airAlso: TNI: Transnasal insufflation, Open CPAP, OptiflowWarm and humidified air at rates of 20 L/min will be delivered through a small nasal cannula throughout sleep | Other | High Flow of room air |
Primary outcome
The evening to morning differences in expiratory airflow obstruction (FEV1/FVC)
Time frame: 4 years
Lung function declines over the course of the night. We hypothesize that delivering warm and humidified air at a rate of 20 L/min over the entire night improves morning FEV1 compared to oxygen.
2 secondary outcomes
The percent rate of inspiratory flow limitation.
Time frame: 4 Years
Effect of High flow nasal insufflation of air on exercise capacity (6 minute walk test).
Time frame: One Year
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 5 Oct 2016.
- Background: PubMed 19129290Schneider H, Krishnan V, Pichard LE, Patil SP, Smith PL, Schwartz AR. Inspiratory duty cycle responses to flow limitation predict nocturnal hypoventilation. Eur Respir J. 2009 May;33(5):1068-76. doi: 10.1183/09031936.00063008. Epub 2009 Jan 7.
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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.
Hartmut Schneider, M.D., Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen and High flow of room air in people with COPD, run by Johns Hopkins University at 1 site in United States.
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 2 inclusion and 15 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 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The evening to morning differences in expiratory airflow obstruction (FEV1/FVC) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01764165, which also lists 1 linked publication.
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 5 Oct 2016.