Increasing Adherence to Oral Appliance Therapy for Obstructive Sleep Apnea

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Adherence, Patient
• Intervention / Treatment: Behavioral: adherence promotion techniques; Procedure: Routine Care

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allen Firestone, DDS, MS; Phone Number: 614-292-3874; Email: firestone.17@osu.edu
• Study Contact Backup: Name: Jie Liu, DDS, MS, PhD; Phone Number: 6142920547; Email: liu.7050@osu.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Dental Faculty Practice, Ohio State University
      • Contact: Allen Firestone, DDS, MS; Phone Number: 614-292-3874; Email: firestone.17@osu.edu
      • Principal Investigator: Allen Firestone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multifactor intervention; The experimental group will receive adherence promotion techniques in addition to routine care.	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.
Active Comparator: Control; The control group will receive routine care	Procedure: Routine Care; The control group will receive routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2017
• Primary Completion (Anticipated): July 5, 2022
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: multifactor intervention; oral appliances
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2020H0406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No