Back to results

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 (ESTAMPS)

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Mandibular Retention Device

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring Obstructive Sleep Apnea Syndrome, mandibular repositioning device

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 exclusion criteria

Sites / Locations

CHU Rouen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Narval O.R.M CC™

Narval O.R.M™ trad

Arm Description

First mandibular retention device : Narval O.R.M CC™

Second mandibular retention device : Narval O.R.M TRAD™

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

maximal mandibular propulsion

investigators will measure the maximal mandibular propulsion (in millimeter) at the end of MRD titration

quality of sleep

investigators will use specific quality of sleep questionnaire: Pittsburgh sleep quality index (PSQI),

sleepiness

investigators will use a specific sleepiness questionnaire: Epworth sleepiness scale (ESS)

MRD therapy efficacy

investigators will measure the residual Apnea and Hypopnea Index (AHI) via polygraphy

mandibular positioning

investigators will measure the mandibular positioning under MRD therapy (in millimeter)

Occlusal vertical dimension

investigators will measure the occlusal vertical dimension changes (in millimeter) between the 2 type of MRD

Full Information

NCT ID

NCT02755662

First Posted

April 7, 2016

Last Updated

September 27, 2017

Sponsor

ResMed

1. Study Identification

Unique Protocol Identification Number

NCT02755662

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

May 2016 (undefined)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ResMed

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea Syndrome

Keywords

Obstructive Sleep Apnea Syndrome, mandibular repositioning device

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Narval O.R.M CC™

Arm Type

Active Comparator

Arm Description

First mandibular retention device : Narval O.R.M CC™

Arm Title

Narval O.R.M™ trad

Arm Type

Active Comparator

Arm Description

Second mandibular retention device : Narval O.R.M TRAD™

Intervention Type

Device

Intervention Name(s)

Mandibular Retention Device

Other Intervention Name(s)

Narval O.R.M CC™

Primary Outcome Measure Information:

Title

upper airway volume

Description

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

Time Frame

1 month

Secondary Outcome Measure Information:

Title

maximal mandibular propulsion

Description

investigators will measure the maximal mandibular propulsion (in millimeter) at the end of MRD titration

Time Frame

1 month

Title

quality of sleep

Description

investigators will use specific quality of sleep questionnaire: Pittsburgh sleep quality index (PSQI),

Time Frame

1 month

Title

sleepiness

Description

investigators will use a specific sleepiness questionnaire: Epworth sleepiness scale (ESS)

Time Frame

1 month

Title

MRD therapy efficacy

Description

investigators will measure the residual Apnea and Hypopnea Index (AHI) via polygraphy

Time Frame

1 month

Title

mandibular positioning

Description

investigators will measure the mandibular positioning under MRD therapy (in millimeter)

Time Frame

1 month

Title

Occlusal vertical dimension

Description

investigators will measure the occlusal vertical dimension changes (in millimeter) between the 2 type of MRD

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Baptiste Kerbrat, MD

Organizational Affiliation

CHU Rouen

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Rouen

City

Rouen

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs