Clinical trial NCT05038215: Increasing Adherence to Oral Appliance Therapy for Obstructive Sleep Apnea
Official title: Increasing Adherence to Oral Appliance Therapy for Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Adherence, Patient
Keywords: multifactor intervention
oral appliances
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To determine if the interventions increase adherence in the experimental group compared with a control group receiving the standard protocol.
Primary purpose: TREATMENT

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- 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.


Eligibility criteria: Inclusion Criteria:

* Potential participants must have a diagnosis of OSA and have been referred for an oral appliance to treat this condition. The participants must have no past experience with oral appliances. Patients must be able to read and converse in English.

Exclusion Criteria:

* Participants who cannot read English will be excluded because all educational material in the study is in English.

Primary outcomes:
measure: A multifactorial intervention in addition to standard care increases adherence rates in patients using a titratable oral appliance to treat obstructive sleep apnea (OSA)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Dental Faculty Practice, Ohio State University
state: Ohio
Study officials:
References: