Ignite Creation Date:
2024-05-06 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05038215
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2021-08-31
Brief Title:
Increasing Adherence to Oral Appliance Therapy for Obstructive Sleep Apnea
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Increasing Adherence to Oral Appliance Therapy for Obstructive Sleep Apnea
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Obstructive sleep apnea is a chronic condition that has serious health consequences including increased risk of hypertension type-2 diabetes heart disease stroke and reduced life expectancy This study proposes to use behavioral reinforcement and support to increase adherence to oral appliance therapy for obstructive sleep apnea The control group in the study will receive routine care In addition their oral appliance wear time will be monitored using a sensor built into the appliance Routine care includes an initial 1-hr consult then delivery of the oral appliance with sensor and follow-up appointments at 1 week 1 month 3 months 6 months and 1 year The second experimental group will receive adherence promotion techniques in addition to routine care These adherence promotion techniques can be categorized into 6 methods 1- spousepartner included in a patient counseling session 2- Educational brochure delivery at follow up appointments 3- Electronic remindercommunication system established by patient and provider 4-Follow up communication between primary care physician and orthodontist 5-Celebratory certificate for good adherence with the oral appliance evaluated at 3 month and 6 month visits 6-Gift card delivery 25 when patient schedules a follow up with sleep physician Patients will be followed for within the research protocol for 6 months There are no additional risks involved with the research and the anticipated benefit is to develop methods to increase adherence to treatment for obstructive sleep apnea This will benefit many patients with obstructive sleep apnea who use oral appliances to control the condition
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None