Increasing Adherence to Oral Appliance Therapy for Obstructive Sleep Apnea

Sponsor

Ohio State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05038215

Collaborator

(none)

Enrollment

Location

Arms

83.9

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea Adherence, Patient	Behavioral: adherence promotion techniques Procedure: Routine Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

Increasing Adherence to Oral Appliance Therapy for Obstructive Sleep Apnea

Actual Study Start Date :

Dec 5, 2017

Anticipated Primary Completion Date :

Jul 5, 2022

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

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

Outcome Measures

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) [6 months]
The experimental interventions resulted in statistically significant improvements in patient adherence to treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dental Faculty Practice, Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ohio State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ohio State University

ClinicalTrials.gov Identifier:

NCT05038215

Other Study ID Numbers:

2020H0406

First Posted:

Sep 9, 2021

Last Update Posted:

Sep 9, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ohio State University

multifactor intervention

oral appliances

Additional relevant MeSH terms:

Apnea

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Study Results

No Results Posted as of Sep 9, 2021