Obstructive Sleep Apnea Clinical Trial
Official title:
Can Objective Compliance Monitoring Increase Mandibular Advancement Device Usage in Obstructive Sleep Apnea Patients
Verified date | November 2017 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 38 |
Est. completion date | July 3, 2017 |
Est. primary completion date | June 13, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Kushida CA, Morgenthaler TI, Littner MR, Alessi CA, Bailey D, Coleman J Jr, Friedman L, Hirshkowitz M, Kapen S, Kramer M, Lee-Chiong T, Owens J, Pancer JP; American Academy of Sleep. Practice parameters for the treatment of snoring and Obstructive Sleep Apnea with oral appliances: an update for 2005. Sleep. 2006 Feb;29(2):240-3. — View Citation
Phillips CL, Grunstein RR, Darendeliler MA, Mihailidou AS, Srinivasan VK, Yee BJ, Marks GB, Cistulli PA. Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. Am J Respir Crit Care Med. 2013 Apr 15;187(8):879-87. doi: 10.1164/rccm.201212-2223OC. — View Citation
Vanderveken OM, Dieltjens M, Wouters K, De Backer WA, Van de Heyning PH, Braem MJ. Objective measurement of compliance during oral appliance therapy for sleep-disordered breathing. Thorax. 2013 Jan;68(1):91-6. doi: 10.1136/thoraxjnl-2012-201900. Epub 2012 Sep 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | one month | |
Secondary | Days used for = 15 min | Days the patient wore for = 15 min the SomnoDent Flex with DentiTrac for previous one month | one month | |
Secondary | Days used for = 4 hrs | Days the patient wore for = 4 hrs the SomnoDent Flex with DentiTrac for previous one month | one month |
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