Mouth Breathing Habits Improvement Intervention

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.

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Key information

Conditions

OSA Apnea Dyssomnias Mouth Breathing Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Differences in OSA-related variables before and after the six weeks oral device intervention

Time frame: 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.
Differences in percentage of mouth puffing before and after the six weeks oral device intervention

Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Jun 3, 2022
Registry last updated: Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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