Comparing Auto-adjustable Positive Airway Pressure to Continuous Positive Airway Pressure in Children With Sleep Apnea
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 5 - 20 |
| Updated: | 8/1/2018 |
| Start Date: | October 2012 |
| End Date: | July 14, 2015 |
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.
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.
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.
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.
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.
Inclusion Criteria:
- 5 to 20 years of age
- apnea hypopnea index (AHI) of ≥5 or obstructive hypoventilation
Exclusion Criteria:
- significant cranio-facial abnormalities
- chromosomal abnormalities that would affect compliance
- cerebral palsy
- significant neurological disease or neuromuscular disease
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: Neepa Gurbani, DO
Phone: 513-636-2814
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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