Obstructive Sleep Apnea
Conditions
Brief summary
This study evaluates whether objective compliance monitoring can increase mandibular advancement device (MAD) usage in obstructive sleep apnea (OSA) patients. Half of participants will be assigned to objective compliance monitoring group (experimental group), while the other will be assigned to subjective compliance monitoring group (control group). A physician will prescribe and explain to patients based on data from objective or subjective compliance monitoring.
Detailed description
The design of this study is a randomized controlled trial. Total 40 participants are randomly divided into 2 groups: objective compliance monitoring (n=20) and subjective compliance monitoring (n=20). Both groups wear the same MAD (commercial name: SomnoDent Flex with DentiTrac). They visit Seol National University Hospital at 1, 3, and 6 month after the initiation of MAD. A research coordinator acquires data by downloading from the MAD or by asking the patients, and then transfer the information to the physician. If the patient belongs to objective compliance group, data from the MAD will be transferred to the physician. But if the patient belongs to subjective compliance group, data acquired by asking patients will be transferred to the physician. A physician will prescribe and explain to patients based on data from objective or subjective compliance monitoring.The primary aims is to examine the effectiveness of SomnoDent Flex with DentiTrac, in terms of compliance.
Interventions
DEVICESomnoDent Flex with DentiTrac
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* obstructive sleep apnea patients without a history of soft palate surgery and moderate to severe periodontal disease.
Exclusion criteria
* central sleep apnea * active mandibular disease * tooth grinding * moderate to severe periodontal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average daily use (hours) | one month | The average number of hours the patient wore and did not wear the SomnoDent Flex with DentiTrac for previous one month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days used for ≥ 15 min | one month | Days the patient wore for ≥ 15 min the SomnoDent Flex with DentiTrac for previous one month |
| Days used for ≥ 4 hrs | one month | Days the patient wore for ≥ 4 hrs the SomnoDent Flex with DentiTrac for previous one month |
Countries
South Korea
Outcome results
None listed