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NCT05038215 · ClinicalTrials.gov registry record · NA
Increasing Adherence to Oral Appliance Therapy for Obstructive Sleep Apnea
A NA study of Obstructive Sleep Apnea and Adherence, Patient, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05038215: Completed NA study of Obstructive Sleep Apnea and Adherence, Patient, sponsored by Ohio State University.
NCT05038215 is a NA study of Obstructive Sleep Apnea and Adherence, Patient that has completed, run by Ohio State University. The registered enrollment target is 60 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05038215, a NA study of Obstructive Sleep Apnea and Adherence, Patient, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The experimental interventions resulted in statistically significant improvements in patient adherence to treatment
Conditions Studied
Interventions
- BEHAVIORAL adherence promotion techniques
- PROCEDURE Routine Care
Study Locations (1)
Ohio
- Dental Faculty Practice, Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-12-05 |
| Est. Completion | 2022-09-01 |
| Phase | NA |
What the finished NCT05038215 record still lists
NCT05038215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which adherence promotion techniques is the first listed.
NCT05038215 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05038215 about?
NCT05038215 is a clinical study titled "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 th...
What is the current status of trial NCT05038215?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2017-12-05. Estimated completion is 2022-09-01.
What conditions does trial NCT05038215 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Adherence, Patient.
What interventions are being tested in trial NCT05038215?
The interventions under investigation include: adherence promotion techniques (BEHAVIORAL), Routine Care (PROCEDURE).
Who is sponsoring clinical trial NCT05038215?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05038215 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05038215's enrollment target sits among peer trials
60 86th of 155 higher than 60 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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