A randomized cross-over study of adjustable thermoplastic oral appliances and continuous positive airway pressure in treatment of patients with obstructive sleep apnea

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

TCTR

Registry ID

TCTR20140901002

Enrollment

Registered

2014-09-01

Start date

2014-10-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Obstructive sleep apnea OSA treatment

Interventions

CPAP,Somnoguard

Active Comparator Device,Experimental Device

CPAP,Oral appliance

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. OSA patients aged > 18 years old 2. AHI 5-30 or AHI >30 with O2 sat. >70% 3. positive consents

Exclusion criteria

Exclusion criteria: 1. Temporomandibular joint disorder 2. Maximal advancement of mandible <5 mm. 3. Severe periodontal diseases 4. Inadequate anchoring teeth (<3 teeth in each quadrants) 5. Poorly-controlled systemic diseases e.g. IHD, cancers, COPD, CVA, Epilepsy, dementia, psychiatric illnesses 6. Intolerance to CPAP or OA 7. Not being able to follow-up through the study protocol

Design outcomes

Primary

Measure	Time frame
Quality of life, sleepiness 6 weeks after each treatment arm FOSQ, ESS	—

Secondary

Measure	Time frame
sleep-related indices 6 weeks after each treatment arm home sleep monitoring (WATCH-PAT),Snoring severity 6 weeks after each treatment VAS symptom questionnaires,side effects and satisfaction 6 weeks after each treatment Questionnaires	—

Countries

Thailand

Contacts

Public ContactWish Banhiran

Mahidol University

wishbanh@gmail.com662-419-8040

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

A randomized cross&#45;over study of adjustable thermoplastic oral appliances and continuous positive airway pressure in treatment of patients with obstructive sleep apnea