Mouth Breathing Habits Improvement Intervention

NCT05404438 | Completed DMC

• 1 other identifier: YM107083E
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

OSA

Keywords

mouth breathing; mouth puffing; sleep apnea; oral appliance

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

intervention group

EXPERIMENTAL

single arm study

Other: Oral Appliances

Interventions

Oral Appliances OTHER

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.

intervention group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

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

Taipei, Taiwan

Location

MeSH Terms

Conditions

Mouth Breathing; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Cheryl CH Yang, professor

  Institute of Brain Science ,National Yang-Ming University, Taipei City, Taiwan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 3, 2022
• Study Start: September 9, 2018
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: June 3, 2022

Record last verified: 2018-09

Locations

TW (1)