Organic Pediatric Obstructive Sleep ApneaEarly Phase 1NCT01768065
Nasal Expiratory Positive Airway Pressure for the Treatment of Pediatric Obstructive Sleep Apnea Syndrome
A Early Phase 1 study testing Nasal Expiratory Positive Airway Pressure Device in people with Organic Pediatric Obstructive Sleep Apnea, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This study will evaluate effectiveness and adherence of the nasal expiratory positive airway pressure (NEPAP) device as an an alternate therapy for children with Obstructive Sleep Apnea Syndrome (OSAS). NEPAP is currently approved for use only in adults. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Organic Pediatric Obstructive Sleep Apnea
- What is being tested?
- Nasal Expiratory Positive Airway Pressure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Apr 2013
- Phase
- Early Phase 1
- 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 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects age 5-16 years (note: Due to the size of the devices, it is expected that most children will be at least 8 years old, but a few may be younger. Subjects will be evaluated in clinic to fit for size and habituate to the device)
- OSAS (AHI > 5/hr)
- Subject has had adenotonsillectomy or is not a candidate for adenotonsillectomy
- Subject is non-adherent to CPAP or is seeking an alternative therapy
- Tolerance of NEPAP device during a daytime session
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Who cannot join
- Severe developmental delay thought to involve a high risk of aspiration
- Family does not understand English well enough to perform the standardized, validated questionnaires.
- Age >16 years since results may be similar to adult studies in these older patients.
- Severe breathing disorder (including respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum)
- Severe heart disease (including heart failure)
- An acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection or perforation of the ear drum
- Subjects that do not meet all of the enrollment criteria will not be enrolled. Any violations of these criteria will be reported in accordance with Institutional Review Board (IRB) Policies and Procedures.
- Study members will not recruit females who are known to be pregnant. However, if a subject becomes pregnant during the study, we will continue to use the device. Pregnancy is not an exclusion criterion as positive airway pressure therapy does not harm the pregnant woman or fetus.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
This study will evaluate effectiveness and adherence of the nasal expiratory positive airway pressure (NEPAP) device as an an alternate therapy for children with Obstructive Sleep Apnea Syndrome (OSAS). NEPAP is currently approved for use only in adults.
Read the detailed description
The nasal expiratory positive airway pressure (NEPAP) device has been used to treat OSAS in adults. A disposable device is placed in each nostril at night and attached with adhesive. The device acts as a one-way valve, during inspiration the valve opens, with negligible resistance to flow. During expiration, the valve closes and airflow is directed through small air channels, increasing resistance. The increased resistance helps to maintain the upper airway pressure during the critical end-expiratory period when the upper airway has been found to be most narrow in the breaths preceding an apnea event. In contrast to Continuous Positive Airway Pressure (CPAP) which provides positive pressure during both inspiration and expiration, NEPAP creates pressure during expiration. NEPAP is a potential alternative therapy which is less cumbersome than CPAP and may increase adherence.
- Being tested
- Nasal Expiratory Positive Airway Pressure Device, placebo sham
- Keywords
- NEPAP, CPAP, alternative, OSAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Expiratory Positive Airway Pressure DeviceDevice
assigned to Nasal Expiratory Positive Airway Pressure arm
placebo shamDevice
| Study group | Role | What they receive |
|---|---|---|
| Nasal Expiratory Positive Airway Pressure Devices | Experimental | Nasal Expiratory Positive Airway Pressure Device Receives: Device: Nasal Expiratory Positive Airway Pressure Device |
| placebo sham | Sham comparator | A sham device Receives: Device: placebo sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea hypopnea index
The apnea hypopnea index during polysomnography will be compared between the active device and the placebo nights
Measured: Approximately one week
Secondary outcomes (1)
Adherence using daily logs
Adherence with using devices will be determined by daily logs and collecting used devices
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startJul 2012
- Primary completionApr 2013
- Study completionApr 2013
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 Organic Pediatric Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Tapia, MD, Children's Hospital of Philadelphia
- Investigators
- Carole Marcus, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768065
- Sponsor's protocol ID
- 12-008691
- Status last verified
- Sep 2019
- First submitted
- 10 Jan 2013
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kureshi SA, Gallagher PR, McDonough JM, Cornaglia MA, Maggs J, Samuel J, Traylor J, Marcus CL. Pilot study of nasal expiratory positive airway pressure devices for the treatment of childhood obstructive sleep apnea syndrome. J Clin Sleep Med. 2014 Jun 15;10(6):663-9. doi: 10.5664/jcsm.3796.
PubMed 24932147
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Expiratory Positive Airway Pressure for the Treatment of Pediatric Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT01768065
- Acronym / sponsor ID
- 12-008691
- Keywords
- NEPAP, CPAP, alternative, OSAS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 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 study will evaluate effectiveness and adherence of the nasal expiratory positive airway pressure (NEPAP) device as an an alternate therapy for children with Obstructive Sleep Apnea Syndrome (OSAS). NEPAP is currently approved for use only in adults.
Detailed description
The nasal expiratory positive airway pressure (NEPAP) device has been used to treat OSAS in adults. A disposable device is placed in each nostril at night and attached with adhesive. The device acts as a one-way valve, during inspiration the valve opens, with negligible resistance to flow. During expiration, the valve closes and airflow is directed through small air channels, increasing resistance. The increased resistance helps to maintain the upper airway pressure during the critical end-expiratory period when the upper airway has been found to be most narrow in the breaths preceding an apnea event. In contrast to Continuous Positive Airway Pressure (CPAP) which provides positive pressure during both inspiration and expiration, NEPAP creates pressure during expiration. NEPAP is a potential alternative therapy which is less cumbersome than CPAP and may increase adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Expiratory Positive Airway Pressure Devices | Experimental | Device: Nasal Expiratory Positive Airway Pressure DeviceNasal Expiratory Positive Airway Pressure Device |
| placebo sham | Sham comparator | Device: placebo shamA sham device |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects age 5-16 years (note: Due to the size of the devices, it is expected that most children will be at least 8 years old, but a few may be younger. Subjects will be evaluated in clinic to fit for size and habituate to the device)
- OSAS (AHI > 5/hr)
- Subject has had adenotonsillectomy or is not a candidate for adenotonsillectomy
- Subject is non-adherent to CPAP or is seeking an alternative therapy
- Tolerance of NEPAP device during a daytime session
Key exclusion criteria (8 listed)
- Severe developmental delay thought to involve a high risk of aspiration
- Family does not understand English well enough to perform the standardized, validated questionnaires.
- Age >16 years since results may be similar to adult studies in these older patients.
- Severe breathing disorder (including respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum)
- Severe heart disease (including heart failure)
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 |
|---|---|---|
| Nasal Expiratory Positive Airway Pressure Deviceassigned to Nasal Expiratory Positive Airway Pressure arm | Device | Nasal Expiratory Positive Airway Pressure Devices |
| placebo sham | Device | placebo sham |
Primary outcome
Apnea hypopnea index
Time frame: Approximately one week
The apnea hypopnea index during polysomnography will be compared between the active device and the placebo nights
1 secondary outcome
Adherence using daily logs
Time frame: One month
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 10 Sep 2019.
- Derived from this study: PubMed 24932147Kureshi SA, Gallagher PR, McDonough JM, Cornaglia MA, Maggs J, Samuel J, Traylor J, Marcus CL. Pilot study of nasal expiratory positive airway pressure devices for the treatment of childhood obstructive sleep apnea syndrome. J Clin Sleep Med. 2014 Jun 15;10(6):663-9. doi: 10.5664/jcsm.3796.
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.
Carole Marcus principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nasal Expiratory Positive Airway Pressure Device in people with Organic Pediatric Obstructive Sleep Apnea, run by Children's Hospital of Philadelphia 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 8 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 10 Sep 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Apnea hypopnea index (time frame: Approximately one week). 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 NCT01768065, 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 10 Sep 2019.