Sleep Apnea SyndromesNCT03893552
Upper Airway Stability During Wakefulness and Sleep
A study testing Negative expiratory pressure in people with Sleep Apnea Syndromes and Snoring, run by Université Catholique de Louvain.
Trial summary
Negative expiratory pressure is a technique that has been the focus of many studies in the last few years. Airway response to the application of a negative expiratory pressure (NEP) can be used to detect the presence of upper airway collapsibility. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea Syndromes, Snoring
- What is being tested?
- Negative expiratory pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 30 Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- Patients with COPD
About this study
Negative expiratory pressure is a technique that has been the focus of many studies in the last few years.
Airway response to the application of a negative expiratory pressure (NEP) can be used to detect the presence of upper airway collapsibility. In normal subjects, an increase in expiratory flow is observed while in patients with collapsible upper airway, the flow will show a transient decrease due to airway collapse.
The objectives of this study will be initially to investigate the diagnostic utility of this technique as a noninvasive measurement of the stability of the upper airway in sleep-related breathing disorders. Secondly, we aim to see the sites of airway obstructions, discovered by NEP, through nasal endoscopy. Finally, we aim at testing the utility of NEP technique in the evaluation of therapeutic response. For this purpose, we will apply it in patients before and after airway stabilization interventions like ENT surgery, oropharyngeal exercises, orthodontic mandibular advancement electrical stimulation of the hypoglossal nerve.
- Conditions
- Sleep Apnea Syndromes, Snoring
- Being tested
- Negative expiratory pressure
- Keywords
- Negative expiratory pressure, sleep apnea, Snoring, Sleep-disordered breathing
- Medical subject headings
- Sleep Apnea Syndromes, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative expiratory pressureDevice
Using a cough assist, a negative expiratory pressure will be applied while recording the respiratory flow in patients suffering from sleeping disorders or snoring.
| Study group | Role | What they receive |
|---|---|---|
| Patient with sleep disordered breathing symptoms | Experimental | Patients referring to the clinic of sleep disorders will be asked to participate in this study. A negative expiratory pressure will be applied via a cough-assist attached to a facial mask. Receives: Device: Negative expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Flow limitation during NEP application
see above, using pneumotachograph
Measured: measurement done immediately after inclusion, one time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Mar 2016
- Primary completion30 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALBDEWI Mohamad Ammar, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893552
- Sponsor's protocol ID
- Study 2015/01OCT/521
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Airway Stability During Wakefulness and Sleep
- ClinicalTrials.gov ID
- NCT03893552
- Acronym / sponsor ID
- Study 2015/01OCT/521
- Conditions
- Sleep Apnea Syndromes, Snoring
- Keywords
- Negative expiratory pressure, sleep apnea, Snoring, Sleep-disordered breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 28 Mar 2019 (actual)
- 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.
Negative expiratory pressure is a technique that has been the focus of many studies in the last few years.
Airway response to the application of a negative expiratory pressure (NEP) can be used to detect the presence of upper airway collapsibility. In normal subjects, an increase in expiratory flow is observed while in patients with collapsible upper airway, the flow will show a transient decrease due to airway collapse.
The objectives of this study will be initially to investigate the diagnostic utility of this technique as a noninvasive measurement of the stability of the upper airway in sleep-related breathing disorders. Secondly, we aim to see the sites of airway obstructions, discovered by NEP, through nasal endoscopy. Finally, we aim at testing the utility of NEP technique in the evaluation of therapeutic response. For this purpose, we will apply it in patients before and after airway stabilization interventions like ENT surgery, oropharyngeal exercises, orthodontic mandibular advancement electrical stimulation of the hypoglossal nerve.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with sleep disordered breathing symptoms | Experimental | Device: Negative expiratory pressurePatients referring to the clinic of sleep disorders will be asked to participate in this study. A negative expiratory pressure will be applied via a cough-assist attached to a facial mask. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Patients with COPD
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 |
|---|---|---|
| Negative expiratory pressureUsing a cough assist, a negative expiratory pressure will be applied while recording the respiratory flow in patients suffering from sleeping disorders or snoring. | Device | Patient with sleep disordered breathing symptoms |
Primary outcome
Measure of Flow limitation during NEP application
Time frame: measurement done immediately after inclusion, one time
see above, using pneumotachograph
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 28 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Negative expiratory pressure in people with Sleep Apnea Syndromes and Snoring, run by Université Catholique de Louvain.
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 1 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 28 Mar 2019. 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?
Measure of Flow limitation during NEP application (time frame: measurement done immediately after inclusion, one time). 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 28 Mar 2019.