Skip to content

The role of mouth tape for continuous positive airway pressure in obstructive sleep apnea

The Role of Mouth Tape for CPAP Users in OSA Patients with Mouth Breathing

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250425002
Enrollment
62
Registered
2025-04-25
Start date
2024-11-24
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 Mouth tape, Mouth breathing, CPAP, obstructive sleep apnea

Interventions

Mouth tape with continuous positive airway pressure (CPAP) Tape Selection: The tape used in this study is the same type utilized by doctors at King Chulalongkorn Memorial Hospital to seal the eyes and
Experimental Device,Active Comparator Other
Silicone hypoallergenic tape with CPAP,CPAP

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged at least 18 years 2. Diagnosed of OSA by in-lab polysomnography according to American Academy of Sleep Medicine (AASM) criteria and eligible for CPAP therapy 3. Mouth breathing during CPAP therapy, as observed by healthcare personnel during polysomnography or by bed partner

Exclusion criteria

Exclusion criteria: 1. Uncontrolled nasal symptoms (e.g., nasal congestion or rhinorrhea), defined by a self-reported visual analog scale (VAS) score < 5 for overall nasal symptoms59 2. History of allergy to mouth tape or silicone 3. Non-nasal interface use 4. Significant retrognathia or craniofacial anomalies 5. Palatine tonsil hypertrophy (grade III/IV) 6. Pregnancy 7. Shift work

Design outcomes

Primary

MeasureTime frame
continuous positive airway pressure adherence 30 days average usage time (minutes)

Secondary

MeasureTime frame
Daytime sleepiness 30 days Epworth sleepiness scale (ESS),Snoring 30 days visual analog scale(VAS) score,night awakening 30 days numbers,leakage 30 days litre per minutes,mouth/throat dryness 30 days severity grading,adverse effect of mouth tape 30 days description,continuous positive airway pressure adherence in frequency 30 days days

Countries

Thailand

Contacts

Public ContactAvika Meksukree

Faculty of Medicine, Chulalongkorn University

avika.msk@gmail.com022564000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026