The additive effect of lip strip to oral appliance therapy for obstructive sleep apnea

JRCT ID: jRCTs072210046

Registered date:27/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: obstructive sleep apnea
• Date of first enrollment: 20/10/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Use OA plus lip strip for 2(1-3) weeks

Outcome(s)

• Primary Outcome: apnea and hypopnea index

Secondary Outcome

3%ODI
lowest oxyhemoglobin saturation levels
use of OA or OA plus lip strip (continue or discontinue)
patient preference (OA or OA plus lip strip)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1. OSA patients using OA
2. AHI >=5 and <30

Exclude criteria

1. AHI >= 30
2. Nasal obstruction
3. Patients who are allergic to strip
4. In the event that the investigator or research investigator determines that participation in this study is not appropriate

Related Information

• Primary Sponsor: Ootsuru Mitsunobu