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Clinical study on the effectiveness and reliability of the improved Smart Naso™ for nasalance measurement

Clinical study on the effectiveness and reliability of the improved Smart Naso™ for nasalance measurement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008727
Enrollment
20
Registered
2023-08-22
Start date
2023-02-03
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

None listed

Interventions

Others(non-medical device) : In Visit 1, the examiner measures nasalance for all subjects using Smart Naso™ (a-n) and Nasometer II 6450 (b-n) in random order (Session 1). After a 5-minute break, the

Sponsors

Jeonbuk National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Men and women over 4 years old and under 80 years old 2) Those who fully understand the purpose and procedure of the study and wish to participate in the clinical study through voluntary consent 3) Subjects whose degree of hypernasal tone as a result of the VPI · Articulation Differential Test by auditory perception evaluation by a skilled speech therapist meets the criteria for each group (normal group 0, hypernasal group 1 or more)

Exclusion criteria

Exclusion criteria: 1) Those who cannot maintain a sitting position for more than 15 minutes 2) Those who cannot follow the instructions of the inspector 3) Those who are judged by the researcher to be unfit to participate in clinical research due to other reasons

Design outcomes

Primary

MeasureTime frame
nasalance score

Secondary

MeasureTime frame
nasalance score

Countries

Korea, Republic of

Contacts

Public ContactSeung-Rok Kang

Jeonbuk National University Hospital

srkang@mdctc.or.kr+82-63-259-3458

Outcome results

None listed

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