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

Obstructive Sleep Apnea Syndrome Clinical Trial

— ESTAMPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755662
• Other study ID #: RESMED Estamps 001
• Status: Completed
• Phase: N/A
• First received: April 7, 2016
• Last updated: September 27, 2017
• Start date: May 2016
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 exclusion criteria

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Device:
• Mandibular Retention Device

Locations

Country	Name	City	State
France	CHU Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	upper airway volume	investigators will measure upper airway volume (cm3) changes produced by 2 different Mandibular Retention Devices in Obstructive sleep apnea syndrome (OSA) patients	1 month
Secondary	maximal mandibular propulsion	investigators will measure the maximal mandibular propulsion (in millimeter) at the end of MRD titration	1 month
Secondary	quality of sleep	investigators will use specific quality of sleep questionnaire: Pittsburgh sleep quality index (PSQI),	1 month
Secondary	sleepiness	investigators will use a specific sleepiness questionnaire: Epworth sleepiness scale (ESS)	1 month
Secondary	MRD therapy efficacy	investigators will measure the residual Apnea and Hypopnea Index (AHI) via polygraphy	1 month
Secondary	mandibular positioning	investigators will measure the mandibular positioning under MRD therapy (in millimeter)	1 month
Secondary	Occlusal vertical dimension	investigators will measure the occlusal vertical dimension changes (in millimeter) between the 2 type of MRD	1 month