Status:
COMPLETED
Confounding Factors of Impedance Pneumography
Lead Sponsor:
Revenio Research
Collaborating Sponsors:
Children's Hospital Srebrnjak
Conditions:
Healthy
Sleep Apnea
Eligibility:
All Genders
1-7 years
Brief Summary
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 wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 26 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 27 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03408990
Start Date
January 26 2018
End Date
December 27 2018
Last Update
May 21 2019
Active Locations (1)
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1
Children's Hospital Srebrnjak
Zagreb, Croatia, 10000