RECRUITING

Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia

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Conditions

Obstructive Sleep ApneaHypertonia, MuscleNasal Airway ObstructionToleranceTrisomy 21Down SyndromeSleep Apnea SyndromesSleep Apnea, ObstructiveApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesNeuromuscular ManifestationsNeurologic Manifestations

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).

Official Title

Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia

Quick Facts

Study Start:2022-11-16
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05527652

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Children with Hypotonic Upper Airway Obstruction (HUAO): This includes those who newly diagnosed with obstructive sleep apnea (OSA). These children will undergo overnight polysomnography to determine the presence of OSA (apnea-hypopnea index \[AHI\]\>10 or AHI\>5 with nocturnal hypoxemia defined as oxygen saturation by pulse oximetry \[SpO2\] nadir \<=75%).
  2. * All subjects require the presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors)
  3. * Post adenotonsillectomy or those with contraindications to tonsillectomy.
  4. * Tonsil size 2+ or smaller.
  5. * Parent/caregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate.
  1. * AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI\<5 with hypoxemia.
  2. * Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable
  3. * Active Coronavirus (COVID) 19 infections
  4. * End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values \>60 mmHg for \>10% of sleep time on PSG
  5. * Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible. Some psychiatric conditions may be provoked or exacerbated by OSA, and those most commonly implicated - Attention Deficit/Hyperactivity Disorder, Conduct Disorder, and Oppositional Defiant Disorder - will not be exclusions. However, more pervasive conditions such as severe autism will be excluded.
  6. * Presence of supraglottic airway collapse or more distal airway stenosis or collapse (for example glottic, subglottic stenosis, or concern for distal airway stenosis or malacia)
  7. * Moderate/severe tracheobronchomalacia
  8. * Need for anticoagulative therapy
  9. * Bleeding disorder
  10. * Restrictive thoracic disorders

Contacts and Locations

Study Contact

David Zopf, MD
CONTACT
734-233-4122
davidzop@med.umich.edu
Louise O'Brien, PhD
CONTACT
7342722783
louiseo@med.umich.edu

Principal Investigator

David Zopf, MD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

The University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • David Zopf, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-16
Study Completion Date2026-08

Study Record Updates

Study Start Date2022-11-16
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • Sleep Apnea Syndromes
  • Sleep Apnea, Obstructive
  • Hypertonia, Muscle
  • Apnea
  • Respiration Disorders
  • Respiratory Tract Diseases
  • Sleep Disorders, Intrinsic
  • Dyssomnias
  • Sleep Wake Disorders
  • Nervous System Diseases
  • Neuromuscular Manifestations
  • Neurologic Manifestations

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea
  • Hypertonia, Muscle
  • Nasal Airway Obstruction
  • Tolerance
  • Trisomy 21
  • Down Syndrome