Clinical Impact of 2 Types of Mandibular Retention Devices - Narval O.R.M CadCam Design vs Narval O.R.M Traditional Design - on Obstructive Sleep Apnea (OSA) Therapy: ESTAMPS Study

Clinical Impact of 2 Types of Mandibular Retention Devices - Narval O.R.M Cad Cam Design vs Narval O.R.M Traditional Design - on Obstructive Sleep Apnea Syndrome (OSA) Therapy: ESTAMPS Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02755662

Acronym

ESTAMPS

Enrollment

Registered

2016-04-29

Start date

2016-05-31

Completion date

2017-07-31

Last updated

2017-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Obstructive Sleep Apnea Syndrome, mandibular repositioning device

Brief summary

ESTAMPS is a randomized clinical trial with a crossover design: Main objective is to compare impact of 2 different Mandibular Retention Device (MRD) designs (Narval MRD CadCam (CC) design vs Narval MRD traditional (trad) design) on upper airway volume secondary objectives: To evaluate the maximal mandibular propulsion according to the type of MRD To evaluate benefits on quality of life, sleepiness and OSA symptoms To evaluate impact of MRD design on therapy efficacy and tolerance To evaluate impact of MRD design on mandibular positioning

Detailed description

Hypothesis ORCADES results suggest that Narval O.R.M CC could be more efficient than Narval MRD trad to reduce AHI whatever the initial OSA severity 79% of CC MRD patients have at least an AHI reduction of 50% (vs. 61% with a trad Narval MRD, p=0.0031) 66% of CC MRD patients get a complete answer with an AHI reduction \<10 (vs. 49% with a trad Narval MRD, p=0.0017) The investigators think that differences seen in the ORCADES study between the 2 MRD is due to a different impact on upper airway volume

Interventions

DEVICEMandibular Retention Device

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with a mild OSA syndrome (5\<AHI\<30) and mild to moderate sleepiness without cardiac comorbidities or patients with mild to severe OSA syndrome (IAH\>15) who do not tolerate or refuse CPAP therapy * Patients ≥ 18 years old * Patient is able to fully understand study information and provide written informed consent

Exclusion criteria

* MRD contraindication * Clinical trial classic

Design outcomes

Primary

Measure	Time frame	Description
upper airway volume	1 month	investigators will measure upper airway volume (cm3) changes produced by 2 different Mandibular Retention Devices in Obstructive sleep apnea syndrome (OSA) patients

Secondary

Measure	Time frame	Description
quality of sleep	1 month	investigators will use specific quality of sleep questionnaire: Pittsburgh sleep quality index (PSQI),
sleepiness	1 month	investigators will use a specific sleepiness questionnaire: Epworth sleepiness scale (ESS)
maximal mandibular propulsion	1 month	investigators will measure the maximal mandibular propulsion (in millimeter) at the end of MRD titration
mandibular positioning	1 month	investigators will measure the mandibular positioning under MRD therapy (in millimeter)
Occlusal vertical dimension	1 month	investigators will measure the occlusal vertical dimension changes (in millimeter) between the 2 type of MRD
MRD therapy efficacy	1 month	investigators will measure the residual Apnea and Hypopnea Index (AHI) via polygraphy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026