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PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea (PROMAD)

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Mandibular Advancement Device ( MAD)
Sponsored by
ethisch.comite@uza.be
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring OSAS, American Academy of Sleep Medicine Task Force

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18 years
  • body mass index (BMI) ≤ 35 kg/m²
  • OSAS, as defined by the American Academy of Sleep Medicine Task Force
  • apnea-hypopnea index (AHI) < 50

Exclusion Criteria:

  • Other sleep disorders (i.e. parasomnias)
  • Invasive upper airway surgery for sleep-disordered breathing
  • Known genetic disorders with craniofacial and/or upper airway malformations
  • Use of benzodiazepine and/or antidepressants
  • Known history of psychiatric disease
  • Known history of fibromyalgia and/or chronic fatigue syndrome
  • Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use

Sites / Locations

  • Antwerp University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Mandibular Advancement Device (MAD)

Arm Description

Mandibular Advancement Device (MAD)

Outcomes

Primary Outcome Measures

Predictive value of DISE and CFD
Positive and negative predictive values for AHI based treatment outcome

Secondary Outcome Measures

Full Information

First Posted
January 30, 2012
Last Updated
January 15, 2021
Sponsor
ethisch.comite@uza.be
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1. Study Identification

Unique Protocol Identification Number
NCT01532050
Brief Title
PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea
Acronym
PROMAD
Official Title
PROMAD : Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ethisch.comite@uza.be

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The present research intends to focus clinically on selecting the right type of patient for mandibular advancement devices (MAD) therapy using screening tools such as advanced imaging and computational methods based on CT-Scan images as well as drug-induced sleep nasendoscopy techniques with simulation of the mandibular repositioning. The core of the research project relies on known and established methods accepted in several neighboring fields, but aims at the transfer of this knowledge by integrating it into this new domain. Doing so, the proposed biomedical research is directed towards clinical applications that incorporate innovative developments on the level of the diagnosis and therapy of a specific disease, being obstructive sleep apnea syndrome (OSAS). Furthermore, this study aims at registering objective compliance during MAD therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
OSAS, American Academy of Sleep Medicine Task Force

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mandibular Advancement Device (MAD)
Arm Type
Other
Arm Description
Mandibular Advancement Device (MAD)
Intervention Type
Device
Intervention Name(s)
Mandibular Advancement Device ( MAD)
Primary Outcome Measure Information:
Title
Predictive value of DISE and CFD
Description
Positive and negative predictive values for AHI based treatment outcome
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years body mass index (BMI) ≤ 35 kg/m² OSAS, as defined by the American Academy of Sleep Medicine Task Force apnea-hypopnea index (AHI) < 50 Exclusion Criteria: Other sleep disorders (i.e. parasomnias) Invasive upper airway surgery for sleep-disordered breathing Known genetic disorders with craniofacial and/or upper airway malformations Use of benzodiazepine and/or antidepressants Known history of psychiatric disease Known history of fibromyalgia and/or chronic fatigue syndrome Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
34608859
Citation
Van Gaver H, Op de Beeck S, Dieltjens M, De Backer J, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Functional imaging improves patient selection for mandibular advancement device treatment outcome in sleep-disordered breathing: a prospective study. J Clin Sleep Med. 2022 Mar 1;18(3):739-750. doi: 10.5664/jcsm.9694.
Results Reference
derived
PubMed Identifier
32946702
Citation
Op de Beeck S, Dieltjens M, Azarbarzin A, Willemen M, Verbraecken J, Braem MJ, Wellman A, Sands SA, Vanderveken OM. Mandibular Advancement Device Treatment Efficacy Is Associated with Polysomnographic Endotypes. Ann Am Thorac Soc. 2021 Mar;18(3):511-518. doi: 10.1513/AnnalsATS.202003-220OC.
Results Reference
derived
PubMed Identifier
32267227
Citation
Van de Perck E, Op de Beeck S, Dieltjens M, Vroegop AV, Verbruggen AE, Willemen M, Verbraecken J, Van de Heyning PH, Braem MJ, Vanderveken OM. The relationship between specific nasopharyngoscopic features and treatment deterioration with mandibular advancement devices: a prospective study. J Clin Sleep Med. 2020 Jul 15;16(7):1189-1198. doi: 10.5664/jcsm.8474.
Results Reference
derived
PubMed Identifier
31482830
Citation
Op de Beeck S, Dieltjens M, Verbruggen AE, Vroegop AV, Wouters K, Hamans E, Willemen M, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Phenotypic Labelling Using Drug-Induced Sleep Endoscopy Improves Patient Selection for Mandibular Advancement Device Outcome: A Prospective Study. J Clin Sleep Med. 2019 Aug 15;15(8):1089-1099. doi: 10.5664/jcsm.7796.
Results Reference
derived
PubMed Identifier
26402736
Citation
Dieltjens M, Verbruggen AE, Braem MJ, Wouters K, Verbraecken JA, De Backer WA, Hamans E, Van de Heyning PH, Vanderveken OM. Determinants of Objective Compliance During Oral Appliance Therapy in Patients With Sleep-Disordered Breathing: A Prospective Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Oct;141(10):894-900. doi: 10.1001/jamaoto.2015.1756.
Results Reference
derived

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PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea

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