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

6. september 2019 opdateret af: Ignacio Tapia, MD, Children's Hospital of Philadelphia
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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Children's Hospital of Philadelphia

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

5 år til 16 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. 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)
  2. OSAS (AHI > 5/hr)
  3. Subject has had adenotonsillectomy or is not a candidate for adenotonsillectomy
  4. Subject is non-adherent to CPAP or is seeking an alternative therapy
  5. Tolerance of NEPAP device during a daytime session
  6. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

  1. Severe developmental delay thought to involve a high risk of aspiration
  2. Family does not understand English well enough to perform the standardized, validated questionnaires.
  3. Age >16 years since results may be similar to adult studies in these older patients.
  4. Severe breathing disorder (including respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum)
  5. Severe heart disease (including heart failure)
  6. 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Nasal Expiratory Positive Airway Pressure Devices
Nasal Expiratory Positive Airway Pressure Device
assigned to Nasal Expiratory Positive Airway Pressure arm
Sham-komparator: placebo sham
A sham device

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Apnea hypopnea index
Tidsramme: Approximately one week
The apnea hypopnea index during polysomnography will be compared between the active device and the placebo nights
Approximately one week

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adherence using daily logs
Tidsramme: One month
Adherence with using devices will be determined by daily logs and collecting used devices
One month

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of life
Tidsramme: One Month
The Pediatric Quality of Life (PedsQL) score will be compared at baseline and after one month of device usage
One Month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Carole Marcus, Children's Hospital of Philadelphia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2012

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

10. januar 2013

Først indsendt, der opfyldte QC-kriterier

14. januar 2013

Først opslået (Skøn)

15. januar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. september 2019

Sidst verificeret

1. september 2019

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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