Sleep ApneaNCT01738009
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B
A study testing Induction of flow limitation in people with Sleep Apnea, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN)… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Induction of flow limitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal subjects or patients with OSA
Who cannot join
- Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
- Any medication known to influence breathing, sleep/arousal or muscle physiology
- Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
- Claustrophobia
- Inability to sleep supine
- Allergy to lidocaine or oxymetazoline hydroclhoride
- For women: Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The cause of PEN is unknown. The investigators will test if lung volumes and low respiratory drive play a role in PEN.
Read the detailed description
The mechanisms that lead to airway closure in OSA are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea.
The investigators will test if lung volumes and low respiratory drive play a role in PEN. To this end, the investigators will visualize the pharynx of sleep apnea patients during sleep using a thin endoscope during sleep while simultaneously measuring lung volumes, genioglossus electromyogram, and pharyngeal pressure during flow-limited breaths. Flow limitation will be induced by sustained reductions of continuous positive airway pressure (CPAP).
- Conditions
- Sleep Apnea
- Being tested
- Induction of flow limitation
- Keywords
- Sleep Apnea, Pathophysiology
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of flow limitationOther
| Study group | Role | What they receive |
|---|---|---|
| Induction of flow limitation | Experimental | Flow limitation will be induced by sustained reductions in continuous positive airway pressure during sleep Receives: Other: Induction of flow limitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in peak inspiratory flow
Measured peak inspiratory flow will be compared to predicted peak inspiratory flow during flow restricted breaths.
The time frame for the outcome will be the duration of induced flow limitation (3 minutes each) . Flow limitation will be induced several times during the night. Flow limited breaths will be averaged.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study start8 Dec 2012
- Primary completionJun 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, David Andrew Wellman, Brigham and Women's Hospital
- Investigators
- David A Wellman, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738009
- Sponsor's protocol ID
- 2012P000957B
- Other IDs
- 1R01HL102321-01A1
- Status last verified
- Feb 2022
- First submitted
- 14 Nov 2012
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B
- ClinicalTrials.gov ID
- NCT01738009
- Acronym / sponsor ID
- 2012P000957B
- Conditions
- Sleep Apnea
- Keywords
- Sleep Apnea, Pathophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 8 Dec 2012 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 30 Nov 2012 (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.
In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The cause of PEN is unknown. The investigators will test if lung volumes and low respiratory drive play a role in PEN.
Detailed description
The mechanisms that lead to airway closure in OSA are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea.
The investigators will test if lung volumes and low respiratory drive play a role in PEN. To this end, the investigators will visualize the pharynx of sleep apnea patients during sleep using a thin endoscope during sleep while simultaneously measuring lung volumes, genioglossus electromyogram, and pharyngeal pressure during flow-limited breaths. Flow limitation will be induced by sustained reductions of continuous positive airway pressure (CPAP).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction of flow limitation | Experimental | Other: Induction of flow limitationFlow limitation will be induced by sustained reductions in continuous positive airway pressure during sleep |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal subjects or patients with OSA
Key exclusion criteria (7 listed)
- Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
- Any medication known to influence breathing, sleep/arousal or muscle physiology
- Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
- Claustrophobia
- Inability to sleep supine
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 |
|---|---|---|
| Induction of flow limitation | Other | Induction of flow limitation |
Primary outcome
Difference in peak inspiratory flow
Time frame: 3 minutes
Measured peak inspiratory flow will be compared to predicted peak inspiratory flow during flow restricted breaths. The time frame for the outcome will be the duration of induced flow limitation (3 minutes each) . Flow limitation will be induced several times during the night. Flow limited breaths will be averaged.
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 9 Mar 2022.
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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.
David A Wellman, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction of flow limitation in people with Sleep Apnea, run by Brigham and Women's Hospital 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 1 inclusion and 7 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 9 Mar 2022. 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?
Difference in peak inspiratory flow (time frame: 3 minutes). 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 9 Mar 2022.