NCT05038215

Increasing Adherence to Oral Appliance Therapy for Obstructive Sleep Apnea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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- spouse/partner included in a patient counseling session. 2- Educational brochure delivery at follow up appointments. 3- Electronic reminder/communication 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.

Conditions

• Obstructive Sleep Apnea
• Adherence, Patient

Interventions

Type	Name	Description
BEHAVIORAL	adherence promotion techniques	The experimental group will receive adherence promotion techniques in addition to routine care, including 1-additional information tailored for the spouse/partner, persons living with the patient. 2- Educational material delivered at follow up appointments and by mail at intervals agreed upon by the patient and the clinician. 3- Electronic reminder/communication system established by patient and provider. 4-Follow up communication from the dental provider of the oral appliance to the primary care physician and with patient's approval, their general dentist. 5- After the 3 month follow up visits the patient will be provided with reports about their appliance wear per week. 6-Gift card delivery, $25, at 6 month follow up if a follow up with sleep physician is scheduled.
PROCEDURE	Routine Care	The control group will receive routine care

Timeline

• Start date: 2017-12-05
• Primary completion: 2022-07-05
• Completion: 2022-09-01
• First posted: 2021-09-09
• Last updated: 2024-05-03

Locations

1 site across 1 country: United States