Nasal Expiratory Positive Airway Pressure for the Treatment of Pediatric Obstructive Sleep Apnea Syndrome

NCT01768065 | Completed Early Phase 1

• 1 other identifier: 12-008691
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Organic Pediatric Obstructive Sleep Apnea

Keywords

NEPAP; CPAP; alternative; OSAS

Outcome Measures

Primary Outcomes (1)

• Apnea hypopnea index

  The apnea hypopnea index during polysomnography will be compared between the active device and the placebo nights

  Approximately one week

Secondary Outcomes (1)

• Adherence using daily logs

  One month

Other Outcomes (1)

• Quality of life

  One Month

Study Arms (2)

Nasal Expiratory Positive Airway Pressure Devices

EXPERIMENTAL

Nasal Expiratory Positive Airway Pressure Device

Device: Nasal Expiratory Positive Airway Pressure Device

placebo sham

SHAM COMPARATOR

A sham device

Device: placebo sham

Interventions

Nasal Expiratory Positive Airway Pressure Device DEVICE

assigned to Nasal Expiratory Positive Airway Pressure arm

Nasal Expiratory Positive Airway Pressure Devices

placebo sham DEVICE

placebo sham

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 24932147 DERIVED

Study Officials

• Carole Marcus

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 15, 2013
• Study Start: July 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: September 10, 2019

Record last verified: 2019-09

Locations

US (1)