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Completed

NCT Number: NCT02755662

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 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

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Rouen

Rouen, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandibular Retention Device

Device

Other names: Narval O.R.M CC™

Primary outcomes

  1. upper airway volume

    Time frame: 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 outcomes

  1. maximal mandibular propulsion

    Time frame: 1 month

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

  2. quality of sleep

    Time frame: 1 month

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

  3. sleepiness

    Time frame: 1 month

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

  4. MRD therapy efficacy

    Time frame: 1 month

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

  5. mandibular positioning

    Time frame: 1 month

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

  6. Occlusal vertical dimension

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study 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

Acronym: ESTAMPS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2016
Registry last updated
Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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