Clinical Trial of Tongue Stabilizing Device for Down Syndrome Patients with Obstructive Sleep Apnea

Clinical Trial of Tongue Stabilizing Device for Down Syndrome Patients with Obstructive Sleep Apnea - TSD trial for Down syndrome with OSA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013935

Enrollment

Registered

2014-06-01

Start date

2014-06-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Obstructive Sleep Apnea

Interventions

Treatment by Tongue Stabilizing Device(TSD)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Members of Japan Down Syndrome Society 2)Subjects with symptoms below by screening test(questionnaire and pulse oximeter) - normal level(2< for <18 years, 5< for 18<years) < 3%ODI <30 - more than one OSA related symptoms - 30<3%ODI if already failed conventional treatment such as CPAP 3) more than 6 years old Down syndrome patient with caregiver who understands and agrees with this study protocol

Exclusion criteria

Exclusion criteria: 1) Subjects want conventional treatment such as CPAP or Oral appliance after screening test 2) Subject who is difficult to participate this study because of severe mental problem

Design outcomes

Primary

Measure	Time frame
Percentage of 'Treatment responder' Definition of 'Treatment response': Good Adherence (use more than 70% days), and improvement of 3%ODI or OSA related symptoms	—

Countries

Japan

Contacts

Public ContactHiroko Tsuda

Hiroko Tsuda General Dentistry

htsuda@dent.kyushu-u.ac.jp092-642-6490

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026