Obstructive Sleep ApneaNCT02567448
Pathophysiology of the Upper Airway in Patients With COPD and Concomitant OSA
A study testing Sleep and pulmonary physiologic measurements in people with Obstructive Sleep Apnea, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of study is to evaluate the physiologic effects of pulmonary tissue/structural changes associated with COPD and upper airway inflammation on upper airway collapsibility. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Sleep and pulmonary physiologic measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2015to 11 Aug 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range 40-70 years.
- Demonstrated moderate to severe COPD as determined by spirometry (post-bronchodilator spirometry FEV1/FVC < 0.70 for diagnosing CODP and FEV1<80% predicted for staging)
- Smoking history of ≥ 10 pack-years
- Age range 40-70 years
- Demonstrated no COPD as determined by normal spirometry (post-bronchodilator spirometry FEV1/FVC > 0.70 for diagnosing CODP and FEV1<80% predicted for staging)
- No smoking history as defined by less than 100 cigarettes smoked in a lifetime
Who cannot join
- Metal objects that may interfere with chest CT quantification including presence of a cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile or metal weapon fragment (bullet, shrapnel, shotgun shot) or metal shoulder prosthesis
- Subjects unable to perform spirometry due to:
- chest or abdominal surgery in the past three months
- a heart attack in the last three months
- detached retina or eye surgery in the past three months
- hospitalization for any other heart problem in the past month
Show all 10Show fewer
- History of hypersensitivity to Afrin, Lidocaine or albuterol
- A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
- More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day
- Pregnancy or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92093
About this study
Official title: Pathophysiology of the Upper Airway in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Concomitant Obstructive Sleep Apnea (OSA)
The purpose of study is to evaluate the physiologic effects of pulmonary tissue/structural changes associated with COPD and upper airway inflammation on upper airway collapsibility. Upper airway collapsibility is closely associated with development of obstructive sleep apnea (OSA), which is a common disease characterized by repetitive collapse of upper airway during sleep, leading to hypoxemia and arousal. OSA has important neurocognitive and cardiovascular consequences, especially in patients with COPD.
Participants in this research study will undergo two overnight sleep studies (PSGs), pulmonary function test, and CT scan of the upper airway and chest. The first sleep study will evaluate the sleep breathing disorder and the second sleep study will measure the upper airway collapsibility, called critical closing pressure (Pcrit). Pcrit is measured by a modified continuous positive airway pressure (CPAP) machine which can provide a wide range of pressures between 20 and -20 cmH2O in order to modify upper airway pressure.
Read the detailed description
This is a physiologic study to assess the effects of lower airway and lung tissue changes of COPD on upper airway collapsibility. Increased in lung volume and destruction of alveolar wall in COPD may have opposite and various effects on the upper airway collapsibility, which is an important factor of OSA development.
Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) are very common disorders associated with considerable morbidity, mortality, and healthcare costs. The prevalence of both co-existing conditions is estimated to be ~4% of the general population. This COPD-OSA "overlap" syndrome causes more severe hypoxemia than either COPD or OSA alone and has important clinical consequences, including death. COPD is usually excluded in OSA research and OSA is typically excluded or not assessed in studies of COPD; thus, available information about the "overlap" syndrome is limited. Therefore, it is important to identify patients with both COPD and OSA and determine the mechanisms of poor outcomes for these patients in order to optimize therapy. The pathophysiology of the COPD-OSA syndrome is not well understood. The investigators propose to investigate upper airway (UA) anatomic characteristics and collapsibility as potential underlying mechanisms that may help to explain the negative additive effect of having both conditions. The objectives are to study CT measures of airway anatomy and the critical closing pressure of the upper airway (Pcrit), a gold standard measure of upper airway collapsibility, in patients with COPD-OSA compared with COPD only and normal controls. CT scan of upper airway and chest will allow precise measures of upper airway characteristics and COPD associated alveolar and lower airway ch. angesMeasures of upper airway collapsibility will provide us information about the mechanical nature of the airway and if the patients are more likely to have OSA. Subjects with COPD-OSA may exhibit more upper airway inflammation possibly due to their pre-existing COPD disease and the reoccurring opening and closing of the upper airway due to the OSA. Therefore the investigators would like to assess the degree of inflammation in these patients compared to normal controls.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Sleep and pulmonary physiologic measurements
- Keywords
- Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Overlap syndrome, Pcrit, Critical closing pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep and pulmonary physiologic measurementsOther
Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage
| Study group | Role | What they receive |
|---|---|---|
| COPD Group | Active comparator | Patients who were previously diagnosed of moderate to severe COPD as determined by spirometry. All patients will have sleep and pulmonary physiologic measurements. Receives: Other: Sleep and pulmonary physiologic measurements |
| Normal Control Group | Active comparator | Patients who are healthy, without major medical or sleep problems, and have normal spirometry. All patients will have sleep and pulmonary physiologic measurements. Receives: Other: Sleep and pulmonary physiologic measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical closing pressure (PCrit)
Measured during overnight sleep study
Measured: Baseline
Secondary outcomes (22)
Pharyngeal lavage cell count distribution
Measured: Baseline
Minimal later airway dimension (mLAT)
Measured from upper airway CT scan
Measured: Baseline
Minimal anteroposterior airway dimension (mAP)
Measured from upper airway CT scan
Measured: Baseline
Minimal cross sectional airway area (mCSA)
Measured from upper airway CT scan
Measured: Baseline
Lateral airway dimension on hard palate/uvula/epiglottis level
Measured from upper airway CT scan
Measured: Baseline
Anteroposterior airway dimension on hard palate/uvula/epiglottis level
Measured from upper airway CT scan
Measured: Baseline
Cross-sectional airway area on hard palate/uvula/epiglottis level
Measured from upper airway CT scan
Measured: Baseline
Distance between the lower edge of the mandible and the lower edge of the hyoid (MH)
Measured from upper airway CT scan
Measured: Baseline
Upper airway length
Measured from upper airway CT scan
Measured: Baseline
Width of hard palate
Measured from upper airway CT scan
Measured: Baseline
Nasophayngeal/retropalatal/retroglossal pharyngeal cavity volume
Measured from upper airway CT scan
Measured: Baseline
Volume within the cervico-mandibular bony frame
Measured from upper airway CT scan
Measured: Baseline
Volume of retropalatal/retroglossal soft tissue
Measured: Baseline
Parapharyngeal fat pad volume
Measured: Baseline
Tongue volume
Measured: Baseline
Emphysema score
Measured from CT chest scan
Measured: Baseline
Emphysema distribution
Measured from CT chest scan
Measured: Baseline
Lower airway wall thickness on chest CT scan
Measured from CT chest scan
Measured: Baseline
Forced expiratory volume in 1 second (FEV1)
Measured: Baseline
Total lung capacity (TLC)
Measured: Baseline
Ratio of residual volume / total lung capacity (RV/TLC)
Measured: Baseline
Diffusing capacity of the lung for carbon monoxide (DLCO)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study start1 Jul 2015
- Primary completion11 Aug 2016
- Study completion11 Aug 2016
Why it stopped: Failed to accrue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert L. Owens, University of California, San Diego
- Investigators
- Xavier Soler, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567448
- Sponsor's protocol ID
- UCSD130851
- Status last verified
- May 2020
- First submitted
- 27 Sep 2015
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology of the Upper Airway in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Concomitant Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT02567448
- Acronym / sponsor ID
- UCSD130851
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Overlap syndrome, Pcrit, Critical closing pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to accrue
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 11 Aug 2016 (actual)
- Study completion
- 11 Aug 2016 (actual)
- First posted
- 5 Oct 2015 (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.
The purpose of study is to evaluate the physiologic effects of pulmonary tissue/structural changes associated with COPD and upper airway inflammation on upper airway collapsibility. Upper airway collapsibility is closely associated with development of obstructive sleep apnea (OSA), which is a common disease characterized by repetitive collapse of upper airway during sleep, leading to hypoxemia and arousal. OSA has important neurocognitive and cardiovascular consequences, especially in patients with COPD.
Participants in this research study will undergo two overnight sleep studies (PSGs), pulmonary function test, and CT scan of the upper airway and chest. The first sleep study will evaluate the sleep breathing disorder and the second sleep study will measure the upper airway collapsibility, called critical closing pressure (Pcrit). Pcrit is measured by a modified continuous positive airway pressure (CPAP) machine which can provide a wide range of pressures between 20 and -20 cmH2O in order to modify upper airway pressure.
Detailed description
This is a physiologic study to assess the effects of lower airway and lung tissue changes of COPD on upper airway collapsibility. Increased in lung volume and destruction of alveolar wall in COPD may have opposite and various effects on the upper airway collapsibility, which is an important factor of OSA development.
Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) are very common disorders associated with considerable morbidity, mortality, and healthcare costs. The prevalence of both co-existing conditions is estimated to be ~4% of the general population. This COPD-OSA "overlap" syndrome causes more severe hypoxemia than either COPD or OSA alone and has important clinical consequences, including death. COPD is usually excluded in OSA research and OSA is typically excluded or not assessed in studies of COPD; thus, available information about the "overlap" syndrome is limited. Therefore, it is important to identify patients with both COPD and OSA and determine the mechanisms of poor outcomes for these patients in order to optimize therapy. The pathophysiology of the COPD-OSA syndrome is not well understood. The investigators propose to investigate upper airway (UA) anatomic characteristics and collapsibility as potential underlying mechanisms that may help to explain the negative additive effect of having both conditions. The objectives are to study CT measures of airway anatomy and the critical closing pressure of the upper airway (Pcrit), a gold standard measure of upper airway collapsibility, in patients with COPD-OSA compared with COPD only and normal controls. CT scan of upper airway and chest will allow precise measures of upper airway characteristics and COPD associated alveolar and lower airway ch. angesMeasures of upper airway collapsibility will provide us information about the mechanical nature of the airway and if the patients are more likely to have OSA. Subjects with COPD-OSA may exhibit more upper airway inflammation possibly due to their pre-existing COPD disease and the reoccurring opening and closing of the upper airway due to the OSA. Therefore the investigators would like to assess the degree of inflammation in these patients compared to normal controls.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD Group | Active comparator | Other: Sleep and pulmonary physiologic measurementsPatients who were previously diagnosed of moderate to severe COPD as determined by spirometry. All patients will have sleep and pulmonary physiologic measurements. |
| Normal Control Group | Active comparator | Other: Sleep and pulmonary physiologic measurementsPatients who are healthy, without major medical or sleep problems, and have normal spirometry. All patients will have sleep and pulmonary physiologic measurements. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range 40-70 years.
- Demonstrated moderate to severe COPD as determined by spirometry (post-bronchodilator spirometry FEV1/FVC < 0.70 for diagnosing CODP and FEV1<80% predicted for staging)
- Smoking history of ≥ 10 pack-years
- Age range 40-70 years
- Demonstrated no COPD as determined by normal spirometry (post-bronchodilator spirometry FEV1/FVC > 0.70 for diagnosing CODP and FEV1<80% predicted for staging)
Key exclusion criteria (10 listed)
- Metal objects that may interfere with chest CT quantification including presence of a cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile or metal weapon fragment (bullet, shrapnel, shotgun shot) or metal shoulder prosthesis
- Subjects unable to perform spirometry due to:
- History of hypersensitivity to Afrin, Lidocaine or albuterol
- A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
- More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day
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 |
|---|---|---|
| Sleep and pulmonary physiologic measurementsTwo overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage | Other | COPD Group, Normal Control Group |
Primary outcome
Critical closing pressure (PCrit)
Time frame: Baseline
Measured during overnight sleep study
22 secondary outcomes
Pharyngeal lavage cell count distribution
Time frame: Baseline
Minimal later airway dimension (mLAT)
Time frame: Baseline
Minimal anteroposterior airway dimension (mAP)
Time frame: Baseline
Minimal cross sectional airway area (mCSA)
Time frame: Baseline
Lateral airway dimension on hard palate/uvula/epiglottis level
Time frame: Baseline
Anteroposterior airway dimension on hard palate/uvula/epiglottis level
Time frame: Baseline
Cross-sectional airway area on hard palate/uvula/epiglottis level
Time frame: Baseline
Distance between the lower edge of the mandible and the lower edge of the hyoid (MH)
Time frame: Baseline
Upper airway length
Time frame: Baseline
Width of hard palate
Time frame: Baseline
Nasophayngeal/retropalatal/retroglossal pharyngeal cavity volume
Time frame: Baseline
Volume within the cervico-mandibular bony frame
Time frame: Baseline
Volume of retropalatal/retroglossal soft tissue
Time frame: Baseline
Parapharyngeal fat pad volume
Time frame: Baseline
Tongue volume
Time frame: Baseline
Emphysema score
Time frame: Baseline
Emphysema distribution
Time frame: Baseline
Lower airway wall thickness on chest CT scan
Time frame: Baseline
Forced expiratory volume in 1 second (FEV1)
Time frame: Baseline
Total lung capacity (TLC)
Time frame: Baseline
Ratio of residual volume / total lung capacity (RV/TLC)
Time frame: Baseline
Diffusing capacity of the lung for carbon monoxide (DLCO)
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Failed to accrue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
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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.
Xavier Soler, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep and pulmonary physiologic measurements in people with Obstructive Sleep Apnea, run by University of California, San Diego 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 May 2020. 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 was stopped early (reason given: Failed to accrue). Results are not available in the source record.
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?
Critical closing pressure (PCrit) (time frame: Baseline). 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 7 May 2020.