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Confounding Factors of Impedance Pneumography

R

Revenio Research

Status

Completed

Conditions

Healthy
Sleep Apnea

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03408990
VCS-005

Details and patient eligibility

About

The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® Lung Function Testing System (LFTS) in infants and pre-schoolers during the whole night sleep with the gold standard for sleep recording events, polysomnography, in order to better understand the confounding factors for momentary changes in the impedance pneumography-derived tidal breathing flow-volume (TBFV) curves.

Enrollment

20 patients

Sex

All

Ages

1 to 7 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Group 1: (children referred to sleep study for clinical reasons) Inclusion criteria:

  • Age 1-7 years, both sexes
  • Referred to polysomnography
  • Signed informed consent

Group 2: (healthy children) Inclusion criteria:

  • 2-7 years, both sexes
  • Healthy at the time of inclusion based on history and clinical examination according to the investigator judgement
  • Lung function in the reference range
  • Signed informed consent

Exclusion Criteria:

  • Preterm birth with chronic respiratory disorder of prematurity
  • Significant nasal congestion or adenotonsillar hypertrophy with signs and symptoms of sleep apnea or sleep disordered breathing
  • Chronic rhinosinusitis, synonasal polyposis
  • Personal or family history or clinical evidence of asthma, atopy or other chronic respiratory disorders (high risk for asthma and allergy)
  • Use of asthma rescue or maintenance medication within 4 weeks prior to inclusion
  • Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness (recurrent pneumonia)
  • Hospital-treated for bronchiolitis with residual symptoms
  • Acute respiratory infection or hospitalization because of an acute illness within 4 weeks prior to inclusion
  • Other cardiorespiratory or neurological chronic diseases or states that may significantly alter the overnight breathing pattern
  • Implanted or external active medical devices
  • Long lasting respiratory events during the polysomnography study like continuous upper airway limitation

Trial design

20 participants in 2 patient groups

Sleep study for clinical reasons
Description:
Children referred to sleep study for clinical reasons
Healthy
Description:
Healthy children, no relevant pathologies

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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