Comparing Auto-adjustable Positive Airway Pressure to Continuous Positive Airway Pressure in Children With Sleep Apnea

NCT01846988 | Completed Results

• 1 other identifier: CIN001APAP
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Pediatric Obstructive Sleep Apnea; Auto PAP; Auto-adjustable Positive Airway Pressure; APAP; CPAP

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  end of study visit at 12-16 weeks

Secondary Outcomes (3)

• Michigan Pediatric Sleep Questionnaire

  12-16 weeks

• Epworth Sleepiness Scale Questionnaire

  12-16 weeks

• Comparison of Pediatric Quality of Life Inventory Questionnaire Score Between Baseline and Each Randomization Period

  12-16 weeks

Study Arms (3)

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.

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.

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.

Device: crossover treatment (REMstar Auto A-Flex)

Interventions

crossover treatment (REMstar Auto A-Flex) DEVICE

All subjects will use same device with 4 week crossover of settings of APAP and CPAP

Also known as: REMstar Auto A-Flex

APAP pressurized comparison; Group 1 crossover treatment; Group 2 crossover treatment

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 20 years of age
• apnea hypopnea index (AHI) of ≥5 or obstructive hypoventilation

You may not qualify if:

• significant cranio-facial abnormalities
• chromosomal abnormalities that would affect compliance
• cerebral palsy
• significant neurological disease or neuromuscular disease

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

Small sample size, small number of pre-adolescent subjects, and short term study

Results Point of Contact

• Title: Dr. Neepa Gurbani, Assistant Professor
• Organization: Cincinnati Children's Hospital Medical Center

Neepa.Gurbani@cchmc.org

(513) 736-1814

Study Officials

• Narong Simakajornboon, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Neepa Gurbani, DO

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: May 6, 2013
• Study Start: October 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: September 1, 2019
• Last Updated: April 23, 2021
• Results First Posted: April 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)