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Oral Appliances With and Without Elastic Bands to Treat Obstructive Sleep Apnea: A Randomized Crossover Trial

Primary Purpose

Sleep Apnea, Obstructive

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Oral appliance with elastic bands
Oral appliance without elastic bands
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring oral appliance, elastic bands

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Center of Sleep Medicine, Haukeland University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral appliance with elastic bands

Oral appliance without elastic bands

Arm Description

Oral appliance therapy with elastic bands.

Oral appliance therapy without elastic bands.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 6, 2023
Last Updated
August 3, 2023
Sponsor
University of Bergen
Collaborators
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05987618
Brief Title
Oral Appliances With and Without Elastic Bands to Treat Obstructive Sleep Apnea: A Randomized Crossover Trial
Official Title
Oral Appliances With and Without Elastic Bands to Treat Obstructive Sleep Apnea: A Randomized Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bergen
Collaborators
Haukeland University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
oral appliance, elastic bands

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Masking Description
The technician scoring the sleep recordings investigating the objective effect of oral appliance treatment with or without elastic bands, will be blinded to which treatment modality the patients are using.
Allocation
Randomized
Enrollment
69 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral appliance with elastic bands
Arm Type
Experimental
Arm Description
Oral appliance therapy with elastic bands.
Arm Title
Oral appliance without elastic bands
Arm Type
Active Comparator
Arm Description
Oral appliance therapy without elastic bands.
Intervention Type
Device
Intervention Name(s)
Oral appliance with elastic bands
Other Intervention Name(s)
Masel Geoshapes elastomerics
Intervention Description
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").
Intervention Type
Device
Intervention Name(s)
Oral appliance without elastic bands
Intervention Description
The oral appliance without the elastic bands.
Primary Outcome Measure Information:
Title
Difference in success (>50% reduction in AHI) of oral appliance treatment with and without elastic bands.
Description
The objective effect of the treatment will be measured using ambulatory polypgrahic examination (PG) with a type IV device (Nox T3).
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.
Secondary Outcome Measure Information:
Title
Difference in reported compliance with oral appliance treatment with and without elastic bands.
Description
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.
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.
Title
Difference in reported side effects with oral appliance treatment with and without elastic bands.
Description
Side effects from oral appliance treatment both with and without elastic bands will be reported through questionnaires.
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.
Title
Difference in reported symptoms of anxiety and depression following oral appliance treatment with and without elastic bands.
Description
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.
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.
Title
Difference in subjective reported effect of oral appliance treatment with and without elastic bands.
Description
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.
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.
Title
Difference in reported insomnia and fatigue following oral appliance treatment with and without elastic bands.
Description
Reported insomnia and fatigue following oral appliance treatment will be measured using questionnaires.
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.
Title
Variables associated with success of oral appliance treatment with elastic bands.
Description
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.
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.
Title
Variables affecting choice of treatment after completed trial period (oral appliance with or without elastic bands)
Description
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.
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.
Title
Variables associated with success of oral appliance treatment.
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrik Leidland Opsahl, Master
Phone
41227714
Ext
+47
Email
ulrik.opsahl@uib.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Johansson, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Sleep Medicine, Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrik Leidland Opsahl, Master
Phone
41227714
Ext
+47
Email
ulrik.opsahl@uib.no

12. IPD Sharing Statement

Learn more about this trial

Oral Appliances With and Without Elastic Bands to Treat Obstructive Sleep Apnea: A Randomized Crossover Trial

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