Obstructive Sleep ApneaNCT01846988
Comparing Auto-adjustable Positive Airway Pressure to Continuous Positive Airway Pressure in Children With Sleep Apnea
A study testing crossover treatment (REMstar Auto A-Flex) in people with Obstructive Sleep Apnea, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to determine if auto-adjustable positive airway pressure (APAP) is an effective way to treat obstructive sleep apnea (OSA) in children. APAP is a device similar to continuous positive airway pressure (CPAP) that delivers pressure to the upper airway (nose and throat) to keep the… Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- crossover treatment (REMstar Auto A-Flex)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 5 to 20 years of age
- apnea hypopnea index (AHI) of ≥5 or obstructive hypoventilation
Who cannot join
- significant cranio-facial abnormalities
- chromosomal abnormalities that would affect compliance
- cerebral palsy
- significant neurological disease or neuromuscular disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Efficacy of Auto-adjustable Positive Airway Pressure (APAP) in Pediatric Patients With Obstructive Sleep Apnea (OSA).
The purpose of this research study is to determine if auto-adjustable positive airway pressure (APAP) is an effective way to treat obstructive sleep apnea (OSA) in children. APAP is a device similar to continuous positive airway pressure (CPAP) that delivers pressure to the upper airway (nose and throat) to keep the airway from collapsing while during sleep. The difference is that APAP adjusts the pressure throughout the night with changes in resistance during breathing, and CPAP gives the same amount of pressure the whole time it is worn. APAP is currently widely used to treat adults with OSA, however, this device has not yet been extensively studied in children.
There are two parts to this research study. Subjects will begin using APAP at the time of enrollment for 4 to 8 weeks. The investigators will compare the pressure measured by the APAP device over the 4-8 weeks with the pressure determined by a CPAP titration study. The titration study is a second overnight sleep study that is routinely ordered when a child with sleep apnea starts treatment with CPAP. It tells the doctor what CPAP setting should be used.
Read more
In the second part of this study The investigators will compare the effects of APAP with CPAP to see what is reported as more comfortable and is used during more hours of sleep. This part of the study will last about 8 weeks and each subject will use both CPAP and APAP for 4 weeks each.
Currently when someone is diagnosed with OSA there is a delay in starting treatment with CPAP until the results of the titration study are available. In this research, patients could be allowed to immediately start treatment with APAP. If APAP is found to be as safe and effective as regular CPAP, treatment with APAP could be used as an alternative to CPAP.
Read the detailed description
This is a small clinical trial to test the feasibility of using APAP in children with sleep apnea.
Continuous positive airway pressure (CPAP) is commonly used to treat OSA by delivering a predetermined amount of positive pressure to the patient's upper airway in order to reduce the collapsibility of airway structures during sleep. The commonly accepted method for determining the appropriate pressure setting for children with OSA is through an in-hospital overnight CPAP titration study. Another commonly used treatment modality in adults with OSA is auto-adjustable positive airway pressure (APAP), in which airway patency is maintained by adjusting pressure delivery through the night depending on the needs of the patient as determined by the device. Benefits of APAP compared with CPAP include the ability to initiate therapy without an inpatient CPAP titration study, resulting in more prompt establishment of treatment and cost-savings. Patient adherence may also be significantly improved as the pressure delivered is appropriate for sleep stage and patient position, resulting in greater patient comfort. Utility and efficacy of APAP compared to CPAP have never been evaluated in the pediatric population.
The aim of this study is to establish APAP as an effective means of assessing CPAP pressure for OSA in children, and to determine if APAP therapy confers better treatment adherence and quality of life compared to traditional CPAP. The investigators hypothesize that APAP can effectively approximate the pressure determined by CPAP titration study, that APAP is superior to fixed CPAP in terms of treatment success, and that adherence to therapy will be improved with APAP compared to CPAP.
Forty patients aged 5-20 years will be enrolled in the study. These subjects will be recruited from the pediatric pulmonary or pediatric sleep clinic at Cincinnati Children's Hospital. Patients who are suspected of having OSA will be referred in the usual manner to the sleep center for diagnostic sleep study (PSG). Following the establishment of OSA diagnosis and subsequent enrollment in the study, the subject will begin therapy with APAP which will continue for 4 to 8 weeks. In that period of time the clinically ordered in-hospital CPAP titration study will be completed. The subject will then be randomized to either traditional fixed pressure CPAP at the pressure determined by in-hospital titration or APAP. The subject will receive 4 weeks of treatment in the randomized group (CPAP or APAP) then crossover to 4 weeks in the alternate group (CPAP or APAP). Both patient and researcher will be blinded to the randomization of pressure modality. The total study period will range from 12-16 weeks.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- crossover treatment (REMstar Auto A-Flex)
- Keywords
- Obstructive Sleep Apnea, Pediatric Obstructive Sleep Apnea, Auto PAP, Auto-adjustable Positive Airway Pressure, APAP, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crossover treatment (REMstar Auto A-Flex)Device
Also called REMstar Auto A-Flex
All subjects will use same device with 4 week crossover of settings of APAP and CPAP
| Study group | Role | What they receive |
|---|---|---|
| Group 1 crossover treatment | Active comparator | crossover treatment (REMstar Auto A-Flex) Placed on REMstar Auto A-Flex machine with APAP settings for 4-8 weeks then randomized to 4 weeks APAP settings then 4 weeks CPAP settings. Receives: Device: crossover treatment (REMstar Auto A-Flex) |
| Group 2 crossover treatment | Active comparator | crossover treatment (REMstar Auto A-Flex) Placed on REMstar Auto A-Flex machine with APAP settings for 4-8 weeks then randomized to 4 weeks CPAP settings then 4 weeks APAP settings. Receives: Device: crossover treatment (REMstar Auto A-Flex) |
| APAP pressurized comparison | Active comparator | randomization periods for 6-8 weeks. An in-hospital APAP titration study will average 90th pressure percentile and average CPAP pressure derived from the device will be compared to the CPAP pressure determined by CPAP titration PSG. Subjects will then be randomized to Group 1 first, or Group 2 first, then crossover to the other group. Receives: Device: crossover treatment (REMstar Auto A-Flex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between Optimal Pressure (cm H2O) Derived From APAP run-in Period Versus Result of CPAP Titration Study
The aim of this study is to establish APAP as an effective treatment modality for OSAS in the pediatric population. We hypothesize that APAP can effectively approximate the pressure determined by PSG CPAP titration as measured by the average 90th pressure percentile and average CPAP pressure delivered to the patient. The in-lab CPAP titration PSG following initial diagnosis of OSA is the current standard of therapy. APAP would potentially bridge the gap between the time of diagnosis and the follow up PSG for CPAP titration, allowing for more prompt intervention.
Measured: First visit after APAP run-in at 6-8 weeks
Adherence Comparison of APAP vs.CPAP (% Days Device Used and % Days Device Used >4 Hours)
Randomized crossover period comparison of adherence between APAP and CPAP calculated from therapy usage hours.
Measured: end of study visit at 12-16 weeks
Secondary outcomes (3)
Michigan Pediatric Sleep Questionnaire
Comparison of Michigan pediatric sleep questionnaire score between baseline (at time of enrollment in the study) and each group (APAP, CPAP) after randomization period for the 10 subjects who completed the study. The scale range is from 0 to 1, Normal <0.33, at risk is 0.33-0.55 and >0.55 abnormal.
Measured: 12-16 weeks
Epworth Sleepiness Scale Questionnaire
Comparison of Epworth Sleepiness scale questionnaire score between baseline (at time of enrollment in the study) and each group (APAP, CPAP) after randomization period for the 10 subjects who completed the study. The scale range is from 0 to 24, with a value of 10 or greater suggesting significance for sleep disordered breathing.
Measured: 12-16 weeks
Comparison of Pediatric Quality of Life Inventory Questionnaire Score Between Baseline and Each Randomization Period
Comparison of Pediatric Quality of Life Inventory questionnaire score between baseline (at time of enrollment in the study) and each group (APAP, CPAP) after randomization period for the 10 subjects who completed the study. The scale scores range between 0-100. Higher scores indicate better health related quality of life. Healthy: 81.34-100, at risk: 81.33-65.4, unhealthy <65.4
Measured: 12-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startOct 2012
- Primary completion1 Dec 2018
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Narong Simakajornboon, MD, Principal investigator, Children's Hospital Medical Center, CincinnatiNeepa Gurbani, DO, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846988
- Sponsor's protocol ID
- CIN001APAP
- Status last verified
- Mar 2021
- First submitted
- 22 Apr 2013
- Last updated
- 23 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share individual participant data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Auto-adjustable Positive Airway Pressure (APAP) in Pediatric Patients With Obstructive Sleep Apnea (OSA).
- ClinicalTrials.gov ID
- NCT01846988
- Acronym / sponsor ID
- CIN001APAP
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Pediatric Obstructive Sleep Apnea, Auto PAP, Auto-adjustable Positive Airway Pressure, APAP, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 6 May 2013 (estimated)
- Results
- Posted 23 Apr 2021
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 this research study is to determine if auto-adjustable positive airway pressure (APAP) is an effective way to treat obstructive sleep apnea (OSA) in children. APAP is a device similar to continuous positive airway pressure (CPAP) that delivers pressure to the upper airway (nose and throat) to keep the airway from collapsing while during sleep. The difference is that APAP adjusts the pressure throughout the night with changes in resistance during breathing, and CPAP gives the same amount of pressure the whole time it is worn. APAP is currently widely used to treat adults with OSA, however, this device has not yet been extensively studied in children.
There are two parts to this research study. Subjects will begin using APAP at the time of enrollment for 4 to 8 weeks. The investigators will compare the pressure measured by the APAP device over the 4-8 weeks with the pressure determined by a CPAP titration study. The titration study is a second overnight sleep study that is routinely ordered when a child with sleep apnea starts treatment with CPAP. It tells the doctor what CPAP setting should be used.
In the second part of this study The investigators will compare the effects of APAP with CPAP to see what is reported as more comfortable and is used during more hours of sleep. This part of the study will last about 8 weeks and each subject will use both CPAP and APAP for 4 weeks each.
Currently when someone is diagnosed with OSA there is a delay in starting treatment with CPAP until the results of the titration study are available. In this research, patients could be allowed to immediately start treatment with APAP. If APAP is found to be as safe and effective as regular CPAP, treatment with APAP could be used as an alternative to CPAP.
Detailed description
This is a small clinical trial to test the feasibility of using APAP in children with sleep apnea.
Continuous positive airway pressure (CPAP) is commonly used to treat OSA by delivering a predetermined amount of positive pressure to the patient's upper airway in order to reduce the collapsibility of airway structures during sleep. The commonly accepted method for determining the appropriate pressure setting for children with OSA is through an in-hospital overnight CPAP titration study. Another commonly used treatment modality in adults with OSA is auto-adjustable positive airway pressure (APAP), in which airway patency is maintained by adjusting pressure delivery through the night depending on the needs of the patient as determined by the device. Benefits of APAP compared with CPAP include the ability to initiate therapy without an inpatient CPAP titration study, resulting in more prompt establishment of treatment and cost-savings. Patient adherence may also be significantly improved as the pressure delivered is appropriate for sleep stage and patient position, resulting in greater patient comfort. Utility and efficacy of APAP compared to CPAP have never been evaluated in the pediatric population.
The aim of this study is to establish APAP as an effective means of assessing CPAP pressure for OSA in children, and to determine if APAP therapy confers better treatment adherence and quality of life compared to traditional CPAP. The investigators hypothesize that APAP can effectively approximate the pressure determined by CPAP titration study, that APAP is superior to fixed CPAP in terms of treatment success, and that adherence to therapy will be improved with APAP compared to CPAP.
Forty patients aged 5-20 years will be enrolled in the study. These subjects will be recruited from the pediatric pulmonary or pediatric sleep clinic at Cincinnati Children's Hospital. Patients who are suspected of having OSA will be referred in the usual manner to the sleep center for diagnostic sleep study (PSG). Following the establishment of OSA diagnosis and subsequent enrollment in the study, the subject will begin therapy with APAP which will continue for 4 to 8 weeks. In that period of time the clinically ordered in-hospital CPAP titration study will be completed. The subject will then be randomized to either traditional fixed pressure CPAP at the pressure determined by in-hospital titration or APAP. The subject will receive 4 weeks of treatment in the randomized group (CPAP or APAP) then crossover to 4 weeks in the alternate group (CPAP or APAP). Both patient and researcher will be blinded to the randomization of pressure modality. The total study period will range from 12-16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 crossover treatment | Active comparator | Device: crossover treatment (REMstar Auto A-Flex)crossover treatment (REMstar Auto A-Flex) Placed on REMstar Auto A-Flex machine with APAP settings for 4-8 weeks then randomized to 4 weeks APAP settings then 4 weeks CPAP settings. |
| Group 2 crossover treatment | Active comparator | Device: crossover treatment (REMstar Auto A-Flex)crossover treatment (REMstar Auto A-Flex) Placed on REMstar Auto A-Flex machine with APAP settings for 4-8 weeks then randomized to 4 weeks CPAP settings then 4 weeks APAP settings. |
| APAP pressurized comparison | Active comparator | Device: crossover treatment (REMstar Auto A-Flex)randomization periods for 6-8 weeks. An in-hospital APAP titration study will average 90th pressure percentile and average CPAP pressure derived from the device will be compared to the CPAP pressure determined by CPAP titration PSG. Subjects will then be randomized to Group 1 first, or Group 2 first, then crossover to the other group. |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 5 to 20 years of age
- apnea hypopnea index (AHI) of ≥5 or obstructive hypoventilation
Key exclusion criteria (4 listed)
- significant cranio-facial abnormalities
- chromosomal abnormalities that would affect compliance
- cerebral palsy
- significant neurological disease or neuromuscular disease
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 |
|---|---|---|
| crossover treatment (REMstar Auto A-Flex)Also: REMstar Auto A-FlexAll subjects will use same device with 4 week crossover of settings of APAP and CPAP | Device | APAP pressurized comparison, Group 1 crossover treatment, Group 2 crossover treatment |
Primary outcome
Difference Between Optimal Pressure (cm H2O) Derived From APAP run-in Period Versus Result of CPAP Titration Study
Time frame: First visit after APAP run-in at 6-8 weeks
The aim of this study is to establish APAP as an effective treatment modality for OSAS in the pediatric population. We hypothesize that APAP can effectively approximate the pressure determined by PSG CPAP titration as measured by the average 90th pressure percentile and average CPAP pressure delivered to the patient. The in-lab CPAP titration PSG following initial diagnosis of OSA is the current standard of therapy. APAP would potentially bridge the gap between the time of diagnosis and the follow up PSG for CPAP titration, allowing for more prompt intervention.
Adherence Comparison of APAP vs.CPAP (% Days Device Used and % Days Device Used >4 Hours)
Time frame: end of study visit at 12-16 weeks
Randomized crossover period comparison of adherence between APAP and CPAP calculated from therapy usage hours.
3 secondary outcomes
Michigan Pediatric Sleep Questionnaire
Time frame: 12-16 weeks
Epworth Sleepiness Scale Questionnaire
Time frame: 12-16 weeks
Comparison of Pediatric Quality of Life Inventory Questionnaire Score Between Baseline and Each Randomization Period
Time frame: 12-16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data at this time.
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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.
Narong Simakajornboon, MD principal investigator
Children's Hospital Medical Center, Cincinnati
Neepa Gurbani, DO principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing crossover treatment (REMstar Auto A-Flex) in people with Obstructive Sleep Apnea, run by Children's Hospital Medical Center, Cincinnati 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 4 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 23 Apr 2021. 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?
Yes. Results are posted in the registry (first posted 23 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Between Optimal Pressure (cm H2O) Derived From APAP run-in Period Versus Result of CPAP Titration Study (time frame: First visit after APAP run-in at 6-8 weeks). The study lists 2 primary outcomes in all. 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 23 Apr 2021.