Mouth Breathing Habits Improvement Intervention
Primary Purpose
OSA
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Oral Appliances
Sponsored by
About this trial
This is an interventional prevention trial for OSA focused on measuring mouth breathing, mouth puffing, sleep apnea, oral appliance
Eligibility Criteria
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.
Sites / Locations
- Faculty of Medicine, and Institute of Brain Science, National Yang-Ming Chiao-Tung University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention group
Arm Description
single arm study
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05404438
First Posted
May 16, 2022
Last Updated
June 1, 2022
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT05404438
Brief Title
Mouth Breathing Habits Improvement Intervention
Official Title
Improvement of Mouth Breathing Habits During Sleep in Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 9, 2018 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OSA
Keywords
mouth breathing, mouth puffing, sleep apnea, oral appliance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
single arm study
Intervention Type
Other
Intervention Name(s)
Oral Appliances
Intervention Description
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 Outcome Measure Information:
Title
Differences in OSA-related variables before and after the six weeks oral device intervention
Description
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.
Time Frame
baseline, six weeks after intervention
Title
Differences in percentage of mouth puffing before and after the six weeks oral device intervention
Description
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.
Time Frame
baseline, six weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl CH Yang, professor
Organizational Affiliation
Institute of Brain Science ,National Yang-Ming University, Taipei City, Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine, and Institute of Brain Science, National Yang-Ming Chiao-Tung University
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Mouth Breathing Habits Improvement Intervention
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