Sleep Apnea, ObstructiveRESTNCT01588275

MRA Therapy Versus CPAP Therapy in Moderate OSAS

A study testing mandibular repositioning appliance (MRA) (SomnoDent) and Continuous positive airway pressure (CPAP) in people with Sleep Apnea, Obstructive, run by University Medical Center Groningen at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the cost-effectiveness and effectiveness of mandibular repositioning appliance (MRA) versus Continuous positive airway pressure (CPAP) therapy in patients with moderate Obstructive Sleep Apnea Syndrome (OSAS). 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?: mandibular repositioning appliance (MRA) (SomnoDent) and Continuous positive airway pressure (CPAP)
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 3 sitesNetherlands
Study dates: 24 May 2012to 31 Dec 2017
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

Individuals who have been subjected to polysomnography and are diagnosed as having moderate (AHI 15-30) OSAS;
Aged ≥ 18 years;

Who cannot join

Medical and psychological criteria:
Patients previously treated for OSAS (e.g. CPAP, MRA);
Morphologic abnormalities of the upper airway (e.g., a compromised nasal passage, enlarged tonsils or adenoids, or upper airway soft-tissue or craniofacial abnormality);
Reported or documented unstable endocrine dysfunction (hypothyroidism, acromegaly, or pituitary adenoma); Reported or documented severe cardiovascular- or pulmonary co-morbidity
Clinically concurrent cardiovascular disease (coronary artery disease, heart failure,cardiac arrhythmias)
CVA within 6 months prior to randomisation

Show all 16Show fewer

Daytime respiratory insufficiency
Severe Chronic Obstructive Pulmonary Disease (COPD) (GOLD 3 or 4; FEV1 / FVC < 70% and FEV1 < 50%);
Other diseases that may impact the evaluation of the results of the study according to the investigator's judgement.
Reported or documented psychological condition precluding informed consent (e.g., mental retardation, depression or schizophrenia);
Whether the patient has unstable endocrine dysfunction, severe cardiovascular- or pulmonary co-morbidity or a psychological condition precluding informed consent, will be assessed by evaluating the patient's medical record.
Dental exclusion criteria:
Extensive periodontal disease or tooth decay;
Active temporomandibular joint disease (including severe bruxism);
Restrictions in mouth opening (< 25mm) or advancement of the mandible <5mm);
Partial or complete edentulism (less than eight teeth in upper or lower jaw).

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

University Medical Center Groningen
Groningen, 9700 RB
Martini Ziekenhuis Groningen
Groningen, 9700 RM
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8901 BR

Other trials in Netherlands

About this study

Official title: Cost-effectiveness of obstRuctivE Sleep Apnea Therapy (REST Study): Comparison of MRA Therapy Versus CPAP Therapy in Moderate OSAS

Read the detailed description

Study design: In a randomized parallel controlled study 86 patients will be randomly assigned to either MRA therapy or CPAP therapy. Group A receives MRA. Group B receives CPAP. The total duration of the study is 12 months. Measurements will be done at baseline, after 3, 6 and 12 months.

Intervention: Group A will be treated with a bibloc MRA (Somnodent). The mandible will be set at 70% of the patient's maximum advancement and will be adjusted to the convenience of the patient. Titration will be continued until symptoms abate or until further advancement causes discomfort.

Group B will be treated with CPAP. Proper CPAP-pressure will be set for each patient separately. Patients are fitted with a comfortable CPAP mask before titration of the CPAP-pressure. For CPAP-titration, patients are instructed to adopt their own typical sleeping habits.

Conditions: Sleep Apnea, Obstructive
Being tested: mandibular repositioning appliance (MRA) (SomnoDent), Continuous positive airway pressure (CPAP)
Keywords: cost-effectiveness, effectiveness, treatment, CPAP, MRA, compliance
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.

mandibular repositioning appliance (MRA) (SomnoDent)Device
Also called bibloc SomnoDent
bibloc MRA type SomnoDent starting at 70% protrusion of the mandibula
Continuous positive airway pressure (CPAP)Procedure or surgery
Proper CPAP-pressure will be set for each patient separately.

Study groups in NCT01588275
Study group	Role	What they receive
MRA therapy	Active comparator	During 12 months patients will be treated with a bibloc MRA (SomnoDent® MAS, SomnoMed Australia/Europe AG). The MRA will be customized by certified dentists or dental-specialists experienced in the field of dental sleep medicine. Receives: Device: mandibular repositioning appliance (MRA) (SomnoDent)
CPAP therapy	Active comparator	During 12 months patients will be treated with Continuous positive airway pressure (CPAP).Treatment with CPAP prevents upper airway collapse by pneumatically "splinting" the upper airway during sleep. Receives: Procedure: Continuous positive airway pressure (CPAP)

What is being measured

The primary outcome is the main question the study is designed to answer.

Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction and quality adjusted life years
Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction measured during polysomnography and quality adjusted life years (QALYs)
Measured: 12 months

Secondary outcomes (6)

Change in quality of life
EQ5D, SF-36, FOSQ questionnaires at baseline and after 3, 6 and 12 months
Measured: 3, 6 and 12 months
Change in Cardiovascular risk
smoking status, change from baseline ambulant blood pressure measurements after 12 months, blood samples, urine sample, accumulation of advanced glycation endproducts (AGEs) in skin tissue
Measured: 6 and 12 months
Change in polysomnographic outcomes
total sleep time, sleep efficiency, minimal oxyhemoglobin saturation, arousals, sleep stages
Measured: 3 and 12 months
Change in activities of daily living
Total distance on 6 minutes walking test Number of steps measured with pedometer
Measured: 3 and 12 months
Compliance
objective compliance by reading out devices subjective compliance by questionnaire
Measured: 3, 6 and 12 months
Side effects
self-reported side effects from device dental and maxillofacial side-effects from both MRA and CPAP
Measured: 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 201231 Dec 2017

First posted30 Apr 2012 (estimated)
Study start24 May 2012
Primary completion31 Dec 2017
Study completion31 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
More trials run by University Medical Center GroningenThe 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
Masking: None (open label)
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01588275
Sponsor's protocol ID: NL34138.042.10
Acronym: REST
Status last verified: May 2018
First submitted: 25 Apr 2012
Last updated: 15 May 2018
Results posted: No
Data monitoring committee: No

Publications

Uniken Venema JAM, Knol-de Vries GE, van Goor H, Westra J, Hoekema A, Wijkstra PJ. Cardiovascular and metabolic effects of a mandibular advancement device and continuous positive airway pressure in moderate obstructive sleep apnea: a randomized controlled trial. J Clin Sleep Med. 2022 Jun 1;18(6):1547-1555. doi: 10.5664/jcsm.9908.
PubMed 35088708
de Vries GE, Hoekema A, Claessen JQPJ, Stellingsma C, Stegenga B, Kerstjens HAM, Wijkstra PJ. Long-Term Objective Adherence to Mandibular Advancement Device Therapy Versus Continuous Positive Airway Pressure in Patients With Moderate Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Nov 15;15(11):1655-1663. doi: 10.5664/jcsm.8034.
PubMed 31739856
de Vries GE, Hoekema A, Vermeulen KM, Claessen JQPJ, Jacobs W, van der Maten J, van der Hoeven JH, Stegenga B, Kerstjens HAM, Wijkstra PJ. Clinical- and Cost-Effectiveness of a Mandibular Advancement Device Versus Continuous Positive Airway Pressure in Moderate Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Oct 15;15(10):1477-1485. doi: 10.5664/jcsm.7980.
PubMed 31596213

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
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All Sleep Apnea, Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cost-effectiveness of obstRuctivE Sleep Apnea Therapy (REST Study): Comparison of MRA Therapy Versus CPAP Therapy in Moderate OSAS
ClinicalTrials.gov ID: NCT01588275
Acronym / sponsor ID: REST / NL34138.042.10
Conditions: Sleep Apnea, Obstructive
Keywords: cost-effectiveness, effectiveness, treatment, CPAP, MRA, compliance
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: University Medical Center GroningenUniversity, hospital or other
Collaborators: VitalAire Nederland BV, SomnoMed Goedegebuure
Study start: 24 May 2012 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 31 Dec 2017 (actual)
First posted: 30 Apr 2012 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MRA therapy	Active comparator	Device: mandibular repositioning appliance (MRA) (SomnoDent)During 12 months patients will be treated with a bibloc MRA (SomnoDent® MAS, SomnoMed Australia/Europe AG). The MRA will be customized by certified dentists or dental-specialists experienced in the field of dental sleep medicine.
CPAP therapy	Active comparator	Procedure: Continuous positive airway pressure (CPAP)During 12 months patients will be treated with Continuous positive airway pressure (CPAP).Treatment with CPAP prevents upper airway collapse by pneumatically "splinting" the upper airway during sleep.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Individuals who have been subjected to polysomnography and are diagnosed as having moderate (AHI 15-30) OSAS;
Aged ≥ 18 years;

Key exclusion criteria (16 listed)

Patients previously treated for OSAS (e.g. CPAP, MRA);
Morphologic abnormalities of the upper airway (e.g., a compromised nasal passage, enlarged tonsils or adenoids, or upper airway soft-tissue or craniofacial abnormality);
Reported or documented unstable endocrine dysfunction (hypothyroidism, acromegaly, or pituitary adenoma); Reported or documented severe cardiovascular- or pulmonary co-morbidity
Clinically concurrent cardiovascular disease (coronary artery disease, heart failure,cardiac arrhythmias)
CVA within 6 months prior to randomisation

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
mandibular repositioning appliance (MRA) (SomnoDent)Also: bibloc SomnoDentbibloc MRA type SomnoDent starting at 70% protrusion of the mandibula	Device	MRA therapy
Continuous positive airway pressure (CPAP)Proper CPAP-pressure will be set for each patient separately.	Procedure or surgery	CPAP therapy

Primary outcome

Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction and quality adjusted life years
Time frame: 12 months
Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction measured during polysomnography and quality adjusted life years (QALYs)

6 secondary outcomes

Change in quality of life
Time frame: 3, 6 and 12 months
Change in Cardiovascular risk
Time frame: 6 and 12 months
Change in polysomnographic outcomes
Time frame: 3 and 12 months
Change in activities of daily living
Time frame: 3 and 12 months
Compliance
Time frame: 3, 6 and 12 months
Side effects
Time frame: 3, 6 and 12 months

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 15 May 2018.
Derived from this study: PubMed 35088708Uniken Venema JAM, Knol-de Vries GE, van Goor H, Westra J, Hoekema A, Wijkstra PJ. Cardiovascular and metabolic effects of a mandibular advancement device and continuous positive airway pressure in moderate obstructive sleep apnea: a randomized controlled trial. J Clin Sleep Med. 2022 Jun 1;18(6):1547-1555. doi: 10.5664/jcsm.9908.
Derived from this study: PubMed 31739856de Vries GE, Hoekema A, Claessen JQPJ, Stellingsma C, Stegenga B, Kerstjens HAM, Wijkstra PJ. Long-Term Objective Adherence to Mandibular Advancement Device Therapy Versus Continuous Positive Airway Pressure in Patients With Moderate Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Nov 15;15(11):1655-1663. doi: 10.5664/jcsm.8034.
Derived from this study: PubMed 31596213de Vries GE, Hoekema A, Vermeulen KM, Claessen JQPJ, Jacobs W, van der Maten J, van der Hoeven JH, Stegenga B, Kerstjens HAM, Wijkstra PJ. Clinical- and Cost-Effectiveness of a Mandibular Advancement Device Versus Continuous Positive Airway Pressure in Moderate Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Oct 15;15(10):1477-1485. doi: 10.5664/jcsm.7980.

Related trials for Sleep Apnea, Obstructive

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)
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Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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RecruitingPhase 1/2
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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.

Grietje E de Vries, MSc study chair

University Medical Center Groningen

Peter J Wijkstra, PhD principal investigator

University Medical Center Groningen

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 16 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 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

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?

Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction and quality adjusted life years (time frame: 12 months). 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 NCT01588275, which also lists 3 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 15 May 2018.