Usefulness of Semi-fixed oral appliance for obstructive sleep apnea patients

JRCT ID: jRCTs072190026

Registered date:06/09/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: obstructive sleep apnea
• Date of first enrollment: 02/10/2019
• Target sample size: 42
• Study type: Interventional

Intervention(s)

1. Semi-fixed OA group: Semi-fixed OA is used for 4 weeks, and 2 weeks later fixed OA is used for 4 weeks.
2. Fixed OA group : Fixed OA is used for 4 weeks, and 2 weeks later Semi-fixed OA is used for 4 weeks.

Outcome(s)

• Primary Outcome: Preventive effect on sleep disordered breathing; lower the apnea and hypopnea index

Secondary Outcome

1. Preventive effect on temporomandibular joint pain
2. Use state of OA: continuance or stop
3. Preventive effect on sleep disordered breathing; higher lowest oxyhemoglobin saturation levels

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both
• Include criteria: OSA Patients
• Exclude criteria: Patients with problem in judgement

Related Information

• Primary Sponsor: Umeda Masahiro