Mouth Breathing Habits Improvement Intervention

Improvement of Mouth Breathing Habits During Sleep in Patients With Obstructive Sleep Apnea

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.

Study Overview

• Status: Completed
• Conditions: OSA
• Intervention / Treatment: Other: Oral Appliances

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: intervention group; single arm study

Other: Oral Appliances; A pre-experimental, single-group pretest-posttest design was performed. At stage one, each participant underwent a 2-day general sleeping test and a 2-day sleeping test with mouth tape. At stage two, participants underwent conventional impressions for TPD and TED appliances and were then randomly assigned to wear the TPD or TED; together for two days of sleeping test with their mouth taped. After a 2-day break (washout), with the same procedure, participants wore the other appliance for another 2-day sleeping test and decided accordingly the optimal appliance that had reduced their ODI scores more. At stage three, participants wore their optimal appliance mouth-taped during sleep for 6 weeks. At the end of the intervention, all participants underwent few days sleeping test for final results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in OSA-related variables before and after the six weeks oral device 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.	baseline, six weeks after intervention
Differences in percentage of mouth puffing before and after the six weeks oral device 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.	baseline, six weeks after intervention

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Investigators: Study Chair: Cheryl CH Yang, professor, Institute of Brain Science ,National Yang-Ming University, Taipei City, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2018
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: sleep apnea; oral appliance; mouth breathing; mouth puffing
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Aspiration; Mouth Breathing
• Other Study ID Numbers: YM107083E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No