Develop a new device using for nasal emission tests in cleft lip and palate

Phase 1

• Conditions: Cleft lip and palate, Cleft palate; Cleft lip and palate

• Registration Number: JPRN-jRCTs062180020
• Lead Sponsor: Doi Rieko

Brief Summary

It was shown that the new device can detect the nasal emission image more than the usual nasal emission test. On the other hand, there was no significant difference in the length value compared with usual one. By age, children were able to use new testing device after the age of approximately three years.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-05
• Study Completion: 2019-08-20
• Results First Posted: 2020-09-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Cleft lip and palate patients:
1)2~6 years old, unlimited by gender
2)post operation of palatoplasty
3)having no-remarkable basal disease for research
healthy children:
1)2~6 years old and year matched with cleft lip and palate patients group
2)no cleft palate
3)having no-remarkable basal disease for research

Exclusion Criteria

Cleft lip and palate patients:
1)not agree with research
2)difficult of periodical follow-up
3)inadequate for research
healthy children:
1)not agree with research
2)inadequate for research

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
difference between conventional method of nasal emission tests and a new device

Secondary Outcome Measures

Name	Time	Method
impression from using<br>relations between each groups and success rate of tests<br>reliability of results from