Confounding Factors of Impedance Pneumography

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03408990
• Date of registration: 16/01/2018
• Prospective Registration: Yes
• Primary sponsor: Revenio Research
• Public title: Confounding Factors of Impedance Pneumography
• Scientific title: Confounding Factors of Impedance Pneumography Signal Changes During Sleep
• Date of first enrolment: January 26, 2018
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03408990
• Study type: Observational

Countries of recruitment

Croatia

Contacts

• Name: Davor Plavec, MD, PhD
• Affiliation: Children's Hospital Srebrnjak

Key inclusion & 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



Age minimum: 1 Year
Age maximum: 7 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sleep Apnea

Healthy

Primary Outcome(s)

Association between sleep stages and tidal breathing flow-volume (TBFV) curves [Time Frame: 1 night]

Secondary Outcome(s)

Association between body/head positions and tidal breathing flow-volume (TBFV) curves [Time Frame: 1 night]

Secondary ID(s)

VCS-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Children's Hospital Srebrnjak