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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
38
Seoul National University Hospital
Seoul, South Korea
Average daily use (hours)
The average number of hours the patient wore and did not wear the SomnoDent Flex with DentiTrac for previous one month
Time frame: one month
Days used for ≥ 15 min
Days the patient wore for ≥ 15 min the SomnoDent Flex with DentiTrac for previous one month
Time frame: one month
Days used for ≥ 4 hrs
Days the patient wore for ≥ 4 hrs the SomnoDent Flex with DentiTrac for previous one month
Time frame: one month
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