Mouth Breathing Habits Improvement Intervention

Not Applicable

Completed

• Conditions: OSA
• Interventions: Other: Oral Appliances

• Registration Number: NCT05404438
• Lead Sponsor: National Yang Ming Chiao Tung University

Brief Summary

This study intends to investigate the improvement in patients with OSA through objective measurement, including oxygen desaturation index (ODI) and the percentage reduction in intermittent mouth puffing (IMP) before and after the intervention. The oral appliances are placed between the tongue and the soft palate to reduce the oral ventilation space. A total of 24 participants aged between 36 and 57 years were identified with ODI above 5 events/hour by measuring their blood oxygen and with an originally designed mouth puffing detector to find out those who were still mouth-puffed when their mouths were taped. A suitable appliance was chosen for the participants between the two originally designed oral appliances, tongue pressed device (TPD) and tongue elevated device (TED), and the intervention lasted for six weeks.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-09
• Study Start: 2018-09-09
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-06-01
• Last Update Submitted: 2022-06-01
• Study First Posted: 2022-06-03
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• (1) aged 20-60 years old,
• (2) having symptoms of OSA including snoring, daytime sleepiness, etc.
• (3) AHI & ODI >=5 events/hour,

Exclusion Criteria

• (1) taken sleep medication within the last two months or were on long-term use,
• (2) reported tobacco, alcohol, caffeine or drug addiction,
• (3) cancer, cardiovascular disease, psychiatric illness, kidney disease, diabetes mellitus, or other sleep disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention group	Oral Appliances	single arm study

Primary Outcome Measures

Name	Time	Method
Differences in percentage of mouth puffing before and after the six weeks oral device intervention	baseline, six weeks after intervention	According to the number of mouth puffing by minutes, mouth puffing signals were divided into four types, including non-mouth puffing (NMP, no or less than 3 times MPSs on both sides), complete mouth puffing (CMP, regularly MPS on both sides, usually above 8-10 times), intermittent mouth puffing (IMP, irregularly MPS in both side, usually between 3-8 times), and side mouth puffing (SMP, showing one-side MPSs) to evaluate the percentage of mouth breathing while sleeping.
Differences in OSA-related variables before and after the six weeks oral device intervention	baseline, six weeks after intervention	According to OSA-related variables, we can analyze participants' ODI (events/hours), mean SpO2 (%), the lowest SpO2(%), and the percentage of total record time with oxygen saturation below 90% (T90) to evaluate their objective sleep quality.

Trial Locations

Locations (1)

Faculty of Medicine, and Institute of Brain Science, National Yang-Ming Chiao-Tung University; 🇨🇳 Taipei, Taiwan