Sleep Apnea, ObstructiveNCT05987618
Oral Appliances With and Without Elastic Bands to Treat Obstructive Sleep Apnea: A Randomized Crossover Trial
A study testing Oral appliance with elastic bands and Oral appliance without elastic bands in people with Sleep Apnea, Obstructive, run by University of Bergen at 1 site in Norway.
Trial summary
The goal of this randomized crossover trial is to investigate the effect of elastic bands attached to oral appliances to minimize mouth opening during sleep in obstructive sleep apnea (OSA) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Oral appliance with elastic bands and Oral appliance without elastic bands
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteNorway
- Study dates
- 15 Apr 2023to 3 Mar 2024
- 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
- Moderate or severe OSA
- Non-compliant and/or non-responder to CPAP-treatment
- Considered for treatment with Somnodent Fusion (second line oral appliance - indicated when retention on remaining teeth is insufficient to retain Narval CC)
- Participate in the "Sleep registry" at Center for Sleep Medicine, Haukeland University Hospital
Who cannot join
- Mild OSA or no OSA
- Considered for treatment with Narval CC (first line oral appliance)
- Patients with insufficient amount of teeth to retain an oral appliance
- Patients with full denture
- Patients that do not speak and/or read Norwegian language
- Patients that are not competent to give informed consent
Trial locations and contacts
1 site in 1 country.
Norway1 site
Center of Sleep Medicine, Haukeland University Hospital
Bergen, 5021
About this study
The goal of this randomized crossover trial is to investigate the effect of elastic bands attached to oral appliances to minimize mouth opening during sleep in obstructive sleep apnea (OSA) patients. The main questions it aims to answer are:
- Are the success rates (>50% reduction of AHI) of oral appliances with elastic bands superior to oral appliances treatment without elastic bands in treatment of moderate and severe OSA?
- Are there predictors that can identify patients that will benefit from use of elastic bands in oral appliance treatment of OSA?
- Are there predictors that can identify patients that are classified as non-responders to oral appliance treatment in general, both with and without elastic bands?
Read more
Participants will be treated with oral appliances with and without elastic bands for 3 weeks, in randomized order. At the end of each 3-week period, the effect of the treatment will be investigated with sleep registrations and questionnaires.
After the completion of both 3-week periodes, patients will continue using their preferred treatment modality (with or without elastic bands) and the oral appliance will be titrated if suboptimal treatment effect.
Read the detailed description
69 patients with moderate or severe OSA referred to Center of Sleep Medicine, Haukeland University Hospital (HUS), for oral appliance treatment will be invited to participate in the study.
The oral appliances will be produced with 63% and 69% of maximal protrusion for patients with moderate and severe OSA, respectively. Patients will be randomized to treatment with or without elastic bands before the oral appliance is fitted to the patient.
3 weeks after delivery, the subjective and objective effect of the treatment are investigated with questionnaires and home sleep testing with polygraphic sleep apnea recordings. The sleep recordings will be manually scored using scoring rules in accordance with the 2012 AASM guidelines. All sleep recording will be scored by the sane technician blinded to the treatment modality (with or without elastics).
Following, the patients will change treatment modality (with or without elastics), with identical investigation of objective and subjective treatment effect after 3 weeks of treatment.
If patients are not able to use their oral appliance due to side effects/discomfort at any point during the 3 week period, the issues are handled adequately, and control of the treatment is postponed for 2 week if remaining time to the planned control is <2 weeks. Patients are encouraged to make contact if side effects/discomfort related to the treatment are experienced.
After both treatment modalities (with and without elastic bands) are tested for 3 weeks, patients choose what treatment modality they want to continue treatment using, based on adherence, objective and subjective treatment effect. Treating physician will advice patients to choose the treatment that reduced their apnea-hypopnea index the most.
Objective treatment outcomes are classified following established success criteria:
- Success criterion 1: AHI < 5
- Success criterion 2: AHI < 10 and > 50% reduction of baseline AHI
- Success criterion 3: ≥50% reduction of baseline AHI
- Failure: <50% reduction of AHI from baseline
If success criterion 1 or 2 is not reached using the preferred treatment modality during the initial 3 week period, the oral appliance is titrated until it considered optimal. Following, the objective and subjective effect of the treatment is investigated with questionnaires and sleep recordings similar to initial treatment.
The patients with persistent <50% reduction of AHI from baseline after the oral appliance is optimally titrated will be offered treatment with CPAP.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Oral appliance with elastic bands, Oral appliance without elastic bands
- Keywords
- oral appliance, elastic bands
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral appliance with elastic bandsDevice
Also called Masel Geoshapes elastomerics
The elastic bands are attached to hooks on both the upper and lower appliance, and on both sides. The elastic bands will be carefully selected not to interfere with retention of the oral appliance. The strongest elastic bands that do not interfere with retention of the oral appliance will be chosen, probably within the range of 85-170 grams (3/8" - 3/16").
Oral appliance without elastic bandsDevice
The oral appliance without the elastic bands.
| Study group | Role | What they receive |
|---|---|---|
| Oral appliance with elastic bands | Experimental | Oral appliance therapy with elastic bands. Receives: Device: Oral appliance with elastic bands |
| Oral appliance without elastic bands | Active comparator | Oral appliance therapy without elastic bands. Receives: Device: Oral appliance without elastic bands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in success (>50% reduction in AHI) of oral appliance treatment with and without elastic bands.
The objective effect of the treatment will be measured using ambulatory polypgrahic examination (PG) with a type IV device (Nox T3).
Measured: The difference in success is investigated using PG-measures from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.
Secondary outcomes (8)
Difference in reported compliance with oral appliance treatment with and without elastic bands.
Compliance with oral appliance treatment both with and without elastic bands will be reported through questionnaires regarding average usage per night measured in hours, and average usage per week measured in number of nights.
Measured: The difference in reported compliance will be measured using data from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.
Difference in reported side effects with oral appliance treatment with and without elastic bands.
Side effects from oral appliance treatment both with and without elastic bands will be reported through questionnaires.
Measured: The difference in reported side effects will be measured using data from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.
Difference in reported symptoms of anxiety and depression following oral appliance treatment with and without elastic bands.
Symptoms of anxiety and depression following oral appliance treatment both with and without elastic bands will be reported through questionnaire, using the Hospital Anxiety and Depression Scale.
Measured: Symptoms of anxiety and depression following oral appliance treatment will be measured using data from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.
Difference in subjective reported effect of oral appliance treatment with and without elastic bands.
Subjective effect of the treatment will be measured using questionnaires regarding effect on daytime somnolence, snoring, quality of life, and effect on bed side partners experienced quality of sleep.
Measured: The difference in subjective effect is investigated using the questionnaires from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.
Difference in reported insomnia and fatigue following oral appliance treatment with and without elastic bands.
Reported insomnia and fatigue following oral appliance treatment will be measured using questionnaires.
Measured: The difference is investigated using the questionnaires from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.
Variables associated with success of oral appliance treatment with elastic bands.
Both objective and subjective variables will be investigated to see if they may be associated with success with oral appliance treatment with elastic bands. This may better the selection of which patients are recommended oral appliance treatment with elastic bands. The objective variables investigated will be variables from the PG-examination (AHI, ODI, AHI supine, time in supine position, time <90% SaO2, average SaO2), measures of jaw function and occlusal characteristics (overjet, overbite, max protrusion, max mouth opening, angle class), and TMD-variables. Subjective variables will mainly be investigated to see if there are associations with adherence to oral appliance treatment with elastic bands. Patients will fill out a questionnaire regarding how different variables affect their choice of treatment (oral appliance with or without elastics). Variables included in the questionnaire will be objective effect, subjective effect, comfort and manageability.
Measured: The variables included in the analysis will be extracted from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.
Variables affecting choice of treatment after completed trial period (oral appliance with or without elastic bands)
Following two 3-week periods of oral appliance treatment with and without elastic bands in randomized order, the patients will choose whether they wish to continue oral appliance treatment with or without elastic bands. They will be asked to justify their choice of treatment using a questionnaire, where they will be asked to grade in what degree different variables affected their choice of treatment.
Measured: Variables affecting choice of treatment after completed trial period will be collected after the two 3-week periodes of using oral appliance with and without elastic bands are completed.
Variables associated with success of oral appliance treatment.
Both objective and subjective variables will be investigated to see if they may be associated with success with oral appliance treatment in general. The objective variables investigated will be variables from the PG-examination (AHI, ODI, AHI supine, time in supine position, time <90% SaO2, average SaO2), measures of jaw function and occlusal characteristics (overjet, overbite, max protrusion, max mouth opening, angle class), and TMD-variables. Subjective variables will mainly be investigated to see if there are associations with adherence to oral appliance treatment. The associations between above mentioned variables and success with oral appliance treatment will be investigated, as well as the association between the variables and adherence to oral appliance treatment and quality of life.
Measured: The variables included in the analysis will be extracted from the final control after the oral appliance is considered optimally titrated. This may be after 6 weeks, but if suboptimal effect, it may be from final control >9 weeks after treatment start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start15 Apr 2023
- Primary completion3 Mar 2024
- Study completion3 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Anders Johansson, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987618
- Sponsor's protocol ID
- REKVEST550079
- Status last verified
- May 2024
- First submitted
- 6 Mar 2023
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Opsahl UL, Berge M, Lehmann S, Bjorvatn B, Johansson A. Prediction of non-responders to oral appliance treatment of obstructive sleep apnea: a pilot study. Sleep Breath. 2025 Apr 15;29(2):159. doi: 10.1007/s11325-025-03315-1.
PubMed 40232353
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Appliances With and Without Elastic Bands to Treat Obstructive Sleep Apnea: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT05987618
- Acronym / sponsor ID
- REKVEST550079
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- oral appliance, elastic bands
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 3 Mar 2024 (actual)
- Study completion
- 3 Mar 2024 (actual)
- First posted
- 14 Aug 2023 (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.
The goal of this randomized crossover trial is to investigate the effect of elastic bands attached to oral appliances to minimize mouth opening during sleep in obstructive sleep apnea (OSA) patients. The main questions it aims to answer are:
- Are the success rates (>50% reduction of AHI) of oral appliances with elastic bands superior to oral appliances treatment without elastic bands in treatment of moderate and severe OSA?
- Are there predictors that can identify patients that will benefit from use of elastic bands in oral appliance treatment of OSA?
- Are there predictors that can identify patients that are classified as non-responders to oral appliance treatment in general, both with and without elastic bands?
Participants will be treated with oral appliances with and without elastic bands for 3 weeks, in randomized order. At the end of each 3-week period, the effect of the treatment will be investigated with sleep registrations and questionnaires.
After the completion of both 3-week periodes, patients will continue using their preferred treatment modality (with or without elastic bands) and the oral appliance will be titrated if suboptimal treatment effect.
Detailed description
69 patients with moderate or severe OSA referred to Center of Sleep Medicine, Haukeland University Hospital (HUS), for oral appliance treatment will be invited to participate in the study.
The oral appliances will be produced with 63% and 69% of maximal protrusion for patients with moderate and severe OSA, respectively. Patients will be randomized to treatment with or without elastic bands before the oral appliance is fitted to the patient.
3 weeks after delivery, the subjective and objective effect of the treatment are investigated with questionnaires and home sleep testing with polygraphic sleep apnea recordings. The sleep recordings will be manually scored using scoring rules in accordance with the 2012 AASM guidelines. All sleep recording will be scored by the sane technician blinded to the treatment modality (with or without elastics).
Following, the patients will change treatment modality (with or without elastics), with identical investigation of objective and subjective treatment effect after 3 weeks of treatment.
If patients are not able to use their oral appliance due to side effects/discomfort at any point during the 3 week period, the issues are handled adequately, and control of the treatment is postponed for 2 week if remaining time to the planned control is <2 weeks. Patients are encouraged to make contact if side effects/discomfort related to the treatment are experienced.
After both treatment modalities (with and without elastic bands) are tested for 3 weeks, patients choose what treatment modality they want to continue treatment using, based on adherence, objective and subjective treatment effect. Treating physician will advice patients to choose the treatment that reduced their apnea-hypopnea index the most.
Objective treatment outcomes are classified following established success criteria:
- Success criterion 1: AHI < 5
- Success criterion 2: AHI < 10 and > 50% reduction of baseline AHI
- Success criterion 3: ≥50% reduction of baseline AHI
- Failure: <50% reduction of AHI from baseline
If success criterion 1 or 2 is not reached using the preferred treatment modality during the initial 3 week period, the oral appliance is titrated until it considered optimal. Following, the objective and subjective effect of the treatment is investigated with questionnaires and sleep recordings similar to initial treatment.
The patients with persistent <50% reduction of AHI from baseline after the oral appliance is optimally titrated will be offered treatment with CPAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral appliance with elastic bands | Experimental | Device: Oral appliance with elastic bandsOral appliance therapy with elastic bands. |
| Oral appliance without elastic bands | Active comparator | Device: Oral appliance without elastic bandsOral appliance therapy without elastic bands. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate or severe OSA
- Non-compliant and/or non-responder to CPAP-treatment
- Considered for treatment with Somnodent Fusion (second line oral appliance - indicated when retention on remaining teeth is insufficient to retain Narval CC)
- Participate in the "Sleep registry" at Center for Sleep Medicine, Haukeland University Hospital
Key exclusion criteria (6 listed)
- Mild OSA or no OSA
- Considered for treatment with Narval CC (first line oral appliance)
- Patients with insufficient amount of teeth to retain an oral appliance
- Patients with full denture
- Patients that do not speak and/or read Norwegian language
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 |
|---|---|---|
| Oral appliance with elastic bandsAlso: Masel Geoshapes elastomericsThe elastic bands are attached to hooks on both the upper and lower appliance, and on both sides. The elastic bands will be carefully selected not to interfere with retention of the oral appliance. The strongest elastic bands that do not interfere with retention of the oral appliance will be chosen, probably within the range of 85-170 grams (3/8" - 3/16"). | Device | Oral appliance with elastic bands |
| Oral appliance without elastic bandsThe oral appliance without the elastic bands. | Device | Oral appliance without elastic bands |
Primary outcome
Difference in success (>50% reduction in AHI) of oral appliance treatment with and without elastic bands.
Time frame: The difference in success is investigated using PG-measures from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.
The objective effect of the treatment will be measured using ambulatory polypgrahic examination (PG) with a type IV device (Nox T3).
8 secondary outcomes
Difference in reported compliance with oral appliance treatment with and without elastic bands.
Time frame: The difference in reported compliance will be measured using data from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.
Difference in reported side effects with oral appliance treatment with and without elastic bands.
Time frame: The difference in reported side effects will be measured using data from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.
Difference in reported symptoms of anxiety and depression following oral appliance treatment with and without elastic bands.
Time frame: Symptoms of anxiety and depression following oral appliance treatment will be measured using data from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.
Difference in subjective reported effect of oral appliance treatment with and without elastic bands.
Time frame: The difference in subjective effect is investigated using the questionnaires from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.
Difference in reported insomnia and fatigue following oral appliance treatment with and without elastic bands.
Time frame: The difference is investigated using the questionnaires from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.
Variables associated with success of oral appliance treatment with elastic bands.
Time frame: The variables included in the analysis will be extracted from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.
Variables affecting choice of treatment after completed trial period (oral appliance with or without elastic bands)
Time frame: Variables affecting choice of treatment after completed trial period will be collected after the two 3-week periodes of using oral appliance with and without elastic bands are completed.
Variables associated with success of oral appliance treatment.
Time frame: The variables included in the analysis will be extracted from the final control after the oral appliance is considered optimally titrated. This may be after 6 weeks, but if suboptimal effect, it may be from final control >9 weeks after treatment start.
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 9 May 2024.
- Derived from this study: PubMed 40232353Opsahl UL, Berge M, Lehmann S, Bjorvatn B, Johansson A. Prediction of non-responders to oral appliance treatment of obstructive sleep apnea: a pilot study. Sleep Breath. 2025 Apr 15;29(2):159. doi: 10.1007/s11325-025-03315-1.
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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.
Anders Johansson, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral appliance with elastic bands and Oral appliance without elastic bands in people with Sleep Apnea, Obstructive, run by University of Bergen at 1 site in Norway.
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 4 inclusion and 6 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 9 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 Norway. 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?
Difference in success (>50% reduction in AHI) of oral appliance treatment with and without elastic bands. (time frame: The difference in success is investigated using PG-measures from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05987618, which also lists 1 linked publication.
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 9 May 2024.