Increasing Adherence to Oral Appliance Therapy for Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea, Adherence, Patient
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
adherence promotion techniques
Routine Care
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring multifactor intervention, oral appliances
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.
Sites / Locations
- Dental Faculty Practice, Ohio State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
multifactor intervention
Control
Arm Description
The experimental group will receive adherence promotion techniques in addition to routine care.
The control group will receive routine care
Outcomes
Primary Outcome Measures
A multifactorial intervention in addition to standard care increases adherence rates in patients using a titratable oral appliance to treat obstructive sleep apnea (OSA)
The experimental interventions resulted in statistically significant improvements in patient adherence to treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05038215
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
July 5, 2022 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Adherence, Patient
Keywords
multifactor intervention, oral appliances
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
To determine if the interventions increase adherence in the experimental group compared with a control group receiving the standard protocol.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
After recruitment and informed consent are complete, subjects will be randomized to the control or experimental group using Random.org. This is a true random number service that generates randomness via atmospheric noise.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
multifactor intervention
Arm Type
Experimental
Arm Description
The experimental group will receive adherence promotion techniques in addition to routine care.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group will receive routine care
Intervention Type
Behavioral
Intervention Name(s)
adherence promotion techniques
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Routine Care
Intervention Description
The control group will receive routine care
Primary Outcome Measure Information:
Title
A multifactorial intervention in addition to standard care increases adherence rates in patients using a titratable oral appliance to treat obstructive sleep apnea (OSA)
Description
The experimental interventions resulted in statistically significant improvements in patient adherence to treatment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allen Firestone, DDS, MS
Phone
614-292-3874
Email
firestone.17@osu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Liu, DDS, MS, PhD
Phone
6142920547
Email
liu.7050@osu.edu
Facility Information:
Facility Name
Dental Faculty Practice, Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allen Firestone, DDS, MS
Phone
614-292-3874
Email
firestone.17@osu.edu
First Name & Middle Initial & Last Name & Degree
Allen Firestone
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Increasing Adherence to Oral Appliance Therapy for Obstructive Sleep Apnea
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