Obstructive Sleep ApneaPhase 4COSHNCT02724865
Somnodent vs Herbst in Mild and Moderate OSA Patients
A Phase 4 study testing Somnodent® (Oral appliance therapy) and Herbst® (Oral appliance therapy) in people with Obstructive Sleep Apnea, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Obstructive sleep apnea (OSA) is a common chronic sleep disorder that often requires lifelong care. The prevalence in the Netherlands is estimated around 300.000 patients. Due to longer life expectancy and increase in weight in the general population, its prevalence is expected to rise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Somnodent® (Oral appliance therapy) and Herbst® (Oral appliance therapy)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2016to Jul 2018
- Phase
- Phase 4
- 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
- 18 years and older
- Ability to speak, read, and write Dutch.
- Ability to follow-up.
- Ability to use a computer with internet connection for online questionnaires.
- Diagnosis with symptomatic mild or moderate OSA (5 < AHI < 30).
- Expected to maintain current lifestyle (sports, medicine, diet, etc.)
Who cannot join
- Untreated periodontal problems, dental pain, and a lack of retention possibilities for an MAD.
- Medication used/related to sleeping disorders.
- Evidence of respiratory/sleep disorders other than OSA (eg. central sleep apnea syndrome).
- Systemic disorders (based on medical history and examination; e.g. rheumatoid arthritis)
- Temporomandibular disorders (based on the function examination of the masticatory system).
- Medical history of known causes of tiredness by day, or severe sleep disruption (insomnia, Periodic Limb Movement Disorder, Narcolepsy).
Show all 10Show fewer
- Known medical history of mental retardation, memory disorders, or psychiatric disorders.
- Reversible morphological upper airway abnormalities (e.g. enlarged tonsils). - Inability to provide informed consent.
- simultaneous use of other modalities to treat OSA.
- Previous treatment with a MAD.
Trial locations and contacts
1 site in 1 country.
Jan de Lange, MD, DDS, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center Amsterdam
Amsterdam, 1105 AZ
Maurits de Ruiter, DMD, 0031205662300, m.h.deruiter@amc.nl
Jan de Lange, MD, DMD, PhD, j.delange@amc.uva.nl
About this study
Official title: A Comparison Between Two Different Oral Appliance Therapies: Somnodent vs Herbst Appliance in Patients With Mild and Moderate OSA
Obstructive sleep apnea (OSA) is a common chronic sleep disorder that often requires lifelong care. The prevalence in the Netherlands is estimated around 300.000 patients. Due to longer life expectancy and increase in weight in the general population, its prevalence is expected to rise. Patients with mild and moderate OSA are treated primarily with an oral appliance at present time. Different oral appliances are available, but most used is the mandibular advancement device (MAD). This study focuses on two different types of MAD: the classic Herbst appliance, which is attached to the mandible and the maxilla and has an iron bar to regulate the open space; and the Somnodent, which consists of two separate splints, fixed on the mandible and the maxilla, but has no iron bar attached.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Somnodent® (Oral appliance therapy), Herbst® (Oral appliance therapy)
- Keywords
- Oral Appliance Therapy
- 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.
Somnodent® (Oral appliance therapy)Device
Herbst® (Oral appliance therapy)Device
| Study group | Role | What they receive |
|---|---|---|
| Oral appliance therapy; Somnodent® | Active comparator | Somnodent is a duobloc appliance, which is frequently used in OSA treatment and is titratable. Receives: Device: Somnodent® (Oral appliance therapy) |
| Oral appliance therapy; Herbst® | Active comparator | Herbst is a duobloc appliance, which is frequently used in OSA treatment and is titratable. Receives: Device: Herbst® (Oral appliance therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypnea-Index (AHI)
AHI is measured with polysomnography in hospital
Measured: 12 months
Oxygen-desaturation-Index
ODI is measured with polysomnography in hospital
Measured: 12 months
Secondary outcomes (4)
Epworth Sleeping Scale
Questionnaire
Measured: 12 months
Functional Outcome of Sleep Questionnaire
Questionnaire
Measured: 12 months
Blood pressure
physical examination
Measured: 12 months
Euroqol (EQ-5D-3L)
Questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Centre for Dentistry in Amsterdam
- Responsible party
- Principal investigator, M.H.T. de Ruiter, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724865
- Sponsor's protocol ID
- NL44085.018.13
- Acronym
- COSH
- Status last verified
- Apr 2016
- First submitted
- 14 Mar 2016
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Young TB. Epidemiology of daytime sleepiness: definitions, symptomatology, and prevalence. J Clin Psychiatry. 2004;65 Suppl 16:12-6.
PubMed 15575799Hoekema A, Stegenga B, De Bont LG. Efficacy and co-morbidity of oral appliances in the treatment of obstructive sleep apnea-hypopnea: a systematic review. Crit Rev Oral Biol Med. 2004 Jun 4;15(3):137-55. doi: 10.1177/154411130401500303.
PubMed 15187032Shi X, Lobbezoo F, Chen H, Rosenmoller BRAM, Berkhout E, de Lange J, Aarab G. Effects of mandibular advancement devices on upper airway dimensions in obstructive sleep apnea: responders versus non-responders. Clin Oral Investig. 2023 Sep;27(9):5649-5660. doi: 10.1007/s00784-023-05186-w. Epub 2023 Aug 17.
PubMed 37589748Shi X, Lobbezoo F, Chen H, Rosenmoller BRAM, Berkhout E, de Lange J, Aarab G. Comparisons of the effects of two types of titratable mandibular advancement devices on respiratory parameters and upper airway dimensions in patients with obstructive sleep apnea: a randomized controlled trial. Clin Oral Investig. 2023 May;27(5):2013-2025. doi: 10.1007/s00784-023-04945-z. Epub 2023 Mar 17.
PubMed 36928350
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Two Different Oral Appliance Therapies: Somnodent vs Herbst Appliance in Patients With Mild and Moderate OSA
- ClinicalTrials.gov ID
- NCT02724865
- Acronym / sponsor ID
- COSH / NL44085.018.13
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Oral Appliance Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Academic Centre for Dentistry in Amsterdam
- Study start
- Jan 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 31 Mar 2016 (estimated)
- 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 (OSA) is a common chronic sleep disorder that often requires lifelong care. The prevalence in the Netherlands is estimated around 300.000 patients. Due to longer life expectancy and increase in weight in the general population, its prevalence is expected to rise. Patients with mild and moderate OSA are treated primarily with an oral appliance at present time. Different oral appliances are available, but most used is the mandibular advancement device (MAD). This study focuses on two different types of MAD: the classic Herbst appliance, which is attached to the mandible and the maxilla and has an iron bar to regulate the open space; and the Somnodent, which consists of two separate splints, fixed on the mandible and the maxilla, but has no iron bar attached.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral appliance therapy; Somnodent® | Active comparator | Device: Somnodent® (Oral appliance therapy)Somnodent is a duobloc appliance, which is frequently used in OSA treatment and is titratable. |
| Oral appliance therapy; Herbst® | Active comparator | Device: Herbst® (Oral appliance therapy)Herbst is a duobloc appliance, which is frequently used in OSA treatment and is titratable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and older
- Ability to speak, read, and write Dutch.
- Ability to follow-up.
- Ability to use a computer with internet connection for online questionnaires.
- Diagnosis with symptomatic mild or moderate OSA (5 < AHI < 30).
Key exclusion criteria (10 listed)
- Untreated periodontal problems, dental pain, and a lack of retention possibilities for an MAD.
- Medication used/related to sleeping disorders.
- Evidence of respiratory/sleep disorders other than OSA (eg. central sleep apnea syndrome).
- Systemic disorders (based on medical history and examination; e.g. rheumatoid arthritis)
- Temporomandibular disorders (based on the function examination of the masticatory system).
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 |
|---|---|---|
| Somnodent® (Oral appliance therapy) | Device | Oral appliance therapy; Somnodent® |
| Herbst® (Oral appliance therapy) | Device | Oral appliance therapy; Herbst® |
Primary outcome
Apnea-hypnea-Index (AHI)
Time frame: 12 months
AHI is measured with polysomnography in hospital
Oxygen-desaturation-Index
Time frame: 12 months
ODI is measured with polysomnography in hospital
4 secondary outcomes
Epworth Sleeping Scale
Time frame: 12 months
Functional Outcome of Sleep Questionnaire
Time frame: 12 months
Blood pressure
Time frame: 12 months
Euroqol (EQ-5D-3L)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Background: PubMed 15575799Young TB. Epidemiology of daytime sleepiness: definitions, symptomatology, and prevalence. J Clin Psychiatry. 2004;65 Suppl 16:12-6.
- Results publication: PubMed 15187032Hoekema A, Stegenga B, De Bont LG. Efficacy and co-morbidity of oral appliances in the treatment of obstructive sleep apnea-hypopnea: a systematic review. Crit Rev Oral Biol Med. 2004 Jun 4;15(3):137-55. doi: 10.1177/154411130401500303.
- Derived from this study: PubMed 37589748Shi X, Lobbezoo F, Chen H, Rosenmoller BRAM, Berkhout E, de Lange J, Aarab G. Effects of mandibular advancement devices on upper airway dimensions in obstructive sleep apnea: responders versus non-responders. Clin Oral Investig. 2023 Sep;27(9):5649-5660. doi: 10.1007/s00784-023-05186-w. Epub 2023 Aug 17.
- Derived from this study: PubMed 36928350Shi X, Lobbezoo F, Chen H, Rosenmoller BRAM, Berkhout E, de Lange J, Aarab G. Comparisons of the effects of two types of titratable mandibular advancement devices on respiratory parameters and upper airway dimensions in patients with obstructive sleep apnea: a randomized controlled trial. Clin Oral Investig. 2023 May;27(5):2013-2025. doi: 10.1007/s00784-023-04945-z. Epub 2023 Mar 17.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Jan de Lange, MD, DDS, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Somnodent® (Oral appliance therapy) and Herbst® (Oral appliance therapy) in people with Obstructive Sleep Apnea, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 13 Apr 2016. 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maurits de Ruiter, DDS (0031205662300, m.h.deruiter@amc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypnea-Index (AHI) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT02724865, which also lists 4 linked publications.
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 13 Apr 2016.