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Effects of Positive Airway Pressure (PAP) in Children With Obstructive Sleep Apnea (OSA) (OSA)

3 november 2016 uppdaterad av: University of Tennessee

Neurobehavioral Effects of Positive Airway Pressure (PAP) Therapy in Children With Obstructive Sleep Apnea

Obstructive sleep apnea is a problem for a large number of children and can result in problems with thinking patterns, behaviors and sleep if left untreated. Little is known about how positive airway pressure (PAP) therapy might help children who need treatment for obstructive sleep apnea. We will investigate how PAP therapy might be able to improve thinking patterns, behavior and sleep problems in children with obstructive sleep apnea.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Positive airway pressure (PAP) therapy has been shown to be an effective treatment which can improve neurocognitive performance and sleep patterns in adults with obstructive sleep apnea (OSA). However, the effect of PAP therapy on neurocognitive, behavioral and sleep patterns in school-aged children with OSA is not well known. The goal of this innovative study is to conduct a randomized, double-blind, placebo controlled, trial which will determine the effects of PAP therapy on neurocognitive and behavioral patterns and sleep architecture in children with OSA. A battery of neurocognitive tests and parent behavioral rating assessments will be given to school-aged children with OSA before, after 3 months and again after 6 months of treatment with PAP therapy only; or 3 months of PAP placebo use followed by 3 months of PAP therapy. Full polysomnography and PAP titration sleep studies will be performed following a night of adaptation sleep in a sleep laboratory at all three time points. Compliance to PAP therapy will be monitored on a daily basis with a remote internet-linked communicator that is attached to the participant's PAP pressure generator. The hypothesis of this ground-breaking project is that 3 months of continuous compliance to a regimen of PAP therapy will result in significant improvement in neurocognitive and behavioral patterns and that sleep architecture will be positively changed to become more reflective of normative values for school-aged children. The results of this innovative and ground-breaking study will have far-reaching effects for sleep clinicians and other health care providers in support of the continued use of PAP therapy as a treatment for OSA and to inform the health-care community about the efficacy of PAP therapy on neurocognition and behavior patterns in school-aged children with OSA.

Studietyp

Interventionell

Inskrivning (Faktisk)

79

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Tennessee
      • Memphis, Tennessee, Förenta staterna, 38103
        • LeBonheur Pediatric and Adolescent Sleep Disorders Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

6 år till 12 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Age between 6.0 and 11.9 years
  2. Nocturnal PSG (polysomnography) shows an apnea/hypopnea index of at least 1.5-10 events on average per hour of sleep and an apnea index of less than 1 per hour (mild to moderate OSA group), or, PSG shows an apnea index of 1 or greater PLUS an apnea/hypopnea index of 10.0 or greater (severe OSA group).
  3. English is spoken as the child's primary language.

  4. Willingness to complete study protocol if randomized into the placebo treatment group.

    -

Exclusion Criteria:

  1. The presence of any other diagnosable sleep disorder other than OSA.
  2. Previous use of PAP therapy for sleep disordered breathing at any time in the patient's history
  3. Presence of health problems likely to interfere with neurocognitive test result interpretation, such as previously diagnosed psychiatric illness (i.e., attention-deficit hyperactivity disorder, depression, psychoses) or medical genetic syndromes (i.e., Prader-Willi syndrome, Fragile X).
  4. Presence of a chronic neurological disorder, chronic renal failure, diabetes, rheumatoid arthritis, or another chronic inflammatory condition. -

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Sham Comparator: Sham PAP therapy
Sham PAP will be used with 30 children, and consists of continuous sub-therapeutic levels of air pressure (approximately 1 cm of water) that are delivered through the nasal interface device.
Enhet: Sham PAP therapy
During sleep, the sham PAP device will administer a constant pressure of subtherapeutic air (approximately 1 cm of water) through a custom fit nasal interface chosen for the child's maximum comfort.
Andra namn:
  • CPAP
  • Kontinuerlig terapi med positivt luftvägstryck
  • APAP
Aktiv komparator: Treatment group
30 children will receive active treatment PAP, which consists of automatically adjusted air pressures that are delivered through the nasal interface device at levels which effectively treats the obstructive events.
Enhet: PAP therapy
Nightly use of automatic positive airway pressure delivered at therapeutic levels and to be delivered through a nasal interface device selected to maximize comfort for each child.
Andra namn:
  • CPAP
  • Kontinuerlig terapi med positivt luftvägstryck
  • APAP

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Neurobehavioral and cognitive function
Tidsram: 6-12 months
a battery of tests designed to measure: academic achievement, reaction time, attention, working memory, executive function, decision making and mental flexibility, and fine motor speed and coordination.
6-12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Tennessee

Utredare

  • Huvudutredare: Kristen H Archbold, PhD, RN, University of Tennessee Health Science Center College of Nursing

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2010

Primärt slutförande (Faktisk)

1 september 2016

Avslutad studie (Förväntat)

1 november 2016

Studieregistreringsdatum

Först inskickad

1 juli 2010

Först inskickad som uppfyllde QC-kriterierna

2 juli 2010

Första postat (Uppskatta)

5 juli 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

4 november 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2016

Senast verifierad

1 maj 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 14-03572FB HL102151

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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