Obstructive Sleep ApneaNCT05038215
Increasing Adherence to Oral Appliance Therapy for Obstructive Sleep Apnea
A study testing adherence promotion techniques and Routine Care in people with Obstructive Sleep Apnea and Adherence, Patient, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Adherence, Patient
- What is being tested?
- adherence promotion techniques and Routine Care
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2017to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants who cannot read English will be excluded because all educational material in the study is in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dental Faculty Practice, Ohio State University
Columbus, Ohio, 43210
About this study
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
- Being tested
- adherence promotion techniques, Routine Care
- Keywords
- multifactor intervention, oral appliances
- Medical subject headings
- Sleep Apnea, Obstructive, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adherence promotion techniquesBehavioural
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.
Routine CareProcedure or surgery
The control group will receive routine care
| Study group | Role | What they receive |
|---|---|---|
| multifactor intervention | Experimental | The experimental group will receive adherence promotion techniques in addition to routine care. Receives: Behavioral: adherence promotion techniques |
| Control | Active comparator | The control group will receive routine care Receives: Procedure: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start5 Dec 2017
- Primary completion5 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To determine if the interventions increase adherence in the experimental group compared with a control group receiving the standard protocol.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038215
- Sponsor's protocol ID
- 2020H0406
- Status last verified
- May 2024
- First submitted
- 31 Aug 2021
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Adherence to Oral Appliance Therapy for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05038215
- Acronym / sponsor ID
- 2020H0406
- Conditions
- Obstructive Sleep Apnea, Adherence, Patient
- Keywords
- multifactor intervention, oral appliances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- To determine if the interventions increase adherence in the experimental group compared with a control group receiving the standard protocol.
| Arm | Type | Receives |
|---|---|---|
| multifactor intervention | Experimental | Behavioral: adherence promotion techniquesThe experimental group will receive adherence promotion techniques in addition to routine care. |
| Control | Active comparator | Procedure: Routine CareThe control group will receive routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who cannot read English will be excluded because all educational material in the study is in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adherence promotion techniquesThe 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. | Behavioural | multifactor intervention |
| Routine CareThe control group will receive routine care | Procedure or surgery | Control |
Primary outcome
A multifactorial intervention in addition to standard care increases adherence rates in patients using a titratable oral appliance to treat obstructive sleep apnea (OSA)
Time frame: 6 months
The experimental interventions resulted in statistically significant improvements in patient adherence to treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adherence promotion techniques and Routine Care in people with Obstructive Sleep Apnea and Adherence, Patient, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A multifactorial intervention in addition to standard care increases adherence rates in patients using a titratable oral appliance to treat obstructive sleep apnea (OSA) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.