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Evaluation of obstructive sleep apnoea in prone vs. supine position and investigation of the accuracy of a subjective assessment of the severity of obstructive sleep apnoea syndrome in infants with Pierre Robin sequence.

Evaluation of obstructive sleep apnoea in prone vs. supine position and investigation of the accuracy of a subjective assessment of the severity of obstructive sleep apnoea syndrome in infants with Pierre Robin sequence.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025607
Enrollment
30
Registered
2021-07-08
Start date
2021-04-14
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q87.0

Interventions

Group 1: Sleep laboratory examination for 4h in prone position, then change to supine position for 4h, individual study duration 8h Group 2: Sleep laboratory examination for 4h in supine position, the

Sponsors

Universitätsklinikum Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0 Months to 12 Months

Inclusion criteria

Inclusion criteria: - Children with RS and inpatient admission at the University Children's Hospital in Tübingen. - Communication with parents possible in German - Consent of parents to the study - Recruitment before beginning therapy with the Tübingen therapy concept

Exclusion criteria

Exclusion criteria: - Infants with RS without treatment according to the Tübingen therapy concept - Lack of consent to participate in the study

Design outcomes

Primary

MeasureTime frame
Findings of polysomnography (Mixed/obstructive apnea index MOAI) in prone or supine position before starting therapy.

Secondary

MeasureTime frame
1) Results and score values of the questionnaires compared to the MOAI of the polygraphy 2) Anthropometric measurement values 3) Craniofacial measurement points and distances in 3D photography 4) Jaw Index measurement values

Countries

Germany

Contacts

Public ContactCornelia Wiechers

Klinik für Kinder- und Jugendmedizin Abteilung Neonatologie

Cornelia.Wiechers@med.uni-tuebingen.de07071/2980898

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026