Increasing Adherence to Oral Appliance Therapy for Obstructive Sleep Apnea

NCT05038215 | Completed

• 1 other identifier: 2020H0406
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Adherence, Patient

Keywords

multifactor intervention; oral appliances

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

multifactor intervention

EXPERIMENTAL

The experimental group will receive adherence promotion techniques in addition to routine care.

Behavioral: adherence promotion techniques

Control

ACTIVE COMPARATOR

The control group will receive routine care

Procedure: Routine Care

Interventions

adherence promotion techniques BEHAVIORAL

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.

multifactor intervention

Routine Care PROCEDURE

The control group will receive routine care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Dental Faculty Practice, Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Patient Compliance

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To determine if the interventions increase adherence in the experimental group compared with a control group receiving the standard protocol.

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 9, 2021
• Study Start: December 5, 2017
• Primary Completion: July 5, 2022
• Study Completion: September 1, 2022
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)