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Titration of Oral Appliance Therapy: a Prospective, Randomized Cross-over Trial.

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ClinicalTrials.gov Identifier: NCT03716648
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité, UZA, University Hospital, Antwerp

Brief Summary:

In this prospective randomized cross-over trial, 3 different titration procedures will be compared:

  1. titration of the mandibular advancement device (MAD) in the home setting based on both the physical limits of the patient's mandibular protrusion and the resolution of subjective complaints, as currently often used in routine clinical practice;
  2. an overnight titration PSG using the remotely controlled mandibular positioner (RCMP) with stepwise mandibular protrusion until respiratory events are reduced and
  3. incremental protrusion of the mandible during DISE using the RCMP until upper airway collapse at all collapsible levels is eliminated.

The aim of this study is to prospectively compare the target protrusion, as well as the treatment outcome in terms of treatment efficacy, of the 3 different titration protocols.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Diagnostic Test: DISE-assisted titration Diagnostic Test: PSG-guided titration Device: subjective titration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, crossover study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determination of the Optimal Mandibular Position During Oral Appliance Therapy With a Mandibular Advancement Device in Patients Diagnosed With Obstructive Sleep Apnea.
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Subjective titration
After fitting the MAD, there is a 1-month period during which the patients get used to wearing the device and titrate the MAD based on improvement of subjective complaints. The actual mechanism of titration will be individually trained with each patient.
Device: subjective titration
Titration of the mandibular position based on subjective improvement in symptoms like snoring and excessive daytime sleepiness.

Experimental: DISE-assisted titration
Incremental protrusion of the mandible during drug-induced sleep endoscopy using the remotely controlled mandibular positioner until upper airway collapse at all collapsible levels is eliminated.
Diagnostic Test: DISE-assisted titration
Titration of the mandibular position with the remotely controlled mandibular positioner during drug-induced sleep endoscopy.

Experimental: PSG-guided titration
An overnight titration polysomnograph using the remotely controlled mandibular positioner with stepwise mandibular protrusion until respiratory events are reduced.
Diagnostic Test: PSG-guided titration
Titration of the mandibular position with the remotely controlled mandibular positioner during drug-induced sleep endoscopy.




Primary Outcome Measures :
  1. The amount of protrusion (mm) [ Time Frame: After the patient underwent the three titration procedures, so approximately 4 months after start of the study ]
    The protrusive position that was predicted as the effective target protrusive position during each titration method (subjective titration, RCMP titration PSG and RCMP titration DISE) will be assessed and compared between the different titration methods.


Secondary Outcome Measures :
  1. The apnea/hypopnea index (AHI) derived from the polysomnographic evaluation. [ Time Frame: After the patient underwent the three titration procedures, so approximately 4 months after start of the study ]
    The efficacy of the MAD therapy will be assessed as a measure of treatment outcome by comparingthe baseline AHI with the AHI under MAD therapy.


Other Outcome Measures:
  1. Visual analogue scale for snoring [ Time Frame: After the patient underwent the three titration procedures, so approximately 4 months after start of the study ]
    A standard 10-point visual analogue scale (VAS) ranging from 0 to 10 with 0 equaling no snoring and 10 causing the bed partner to leave the room or sleep separately was used to evaluate the subjective status of snoring, as assessed by the bed partner. Heavy snoring was defined as a VAS snoring index of at least 7. A decrease of at least 3 points on VAS for snoring during treatment with MAD compared to baseline represents a decrease of one level of snoring severity and was therefore considered satisfactory. To be considered as an important'important' reduction, snoring had to be reduced to a snoring index that was no longer evaluated as bothersome, i.e. to a snoring index of ≤ 3.

  2. Epworth sleepiness scale [ Time Frame: After the patient underwent the three titration procedures, so approximately 4 months after start of the study ]
    Hypersomnolence was assessed using the Epworth Sleepiness Scale (ESS), an 8-item questionnaire which takes about three minutes to fill out. It reflects the chance of each person's general level of sleepiness during eight situations of daily life. The subject selects the most appropriate integer score ranging from 0 (would never doze) to 3 (high chance of dozing) for each of the 8 questions. The results are then summed up, with 0 being the minimal and 24 the maximum total ESS score. The higher the ESS score, the higher that person's average sleep propensity in daily life. In general, ESS scores need to be interpreted as follows: 0-5=Lower Normal Daytime Sleepiness, 6-10 = Higher Normal Daytime Sleepiness, 11-12 = Mild Excessive Daytime Sleepiness, 13-15 = Moderate Excessive Daytime Sleepiness, 16-24 =Severe Excessive Daytime Sleepiness.

  3. Checklist Individual Strenght [ Time Frame: After the patient underwent the three titration procedures, so approximately 4 months after start of the study ]
    Fatigue severity was assessed using the Checklist Individual Strength (CIS20R), a 20-item questionnaire that takes around five to ten minutes to fill out. Each question has a statement to be scored on a 7-point Likert scale ranging between 'yes, this is true' to 'no, this is not true'. The total score is calculated as the sum of the responses to the different statements. The maximum CIS20R score is 140, with a score of 76/140 or higher indicating that the patient is at risk for prolonged absence at work. The scale is subdivided in four dimensions of fatigue being fatigue severity (8 items, max. score 56), concentration problems (5 items, max. score 35), reduced motivation (4 items, max. score 28) and activity (3 items, max. score 21).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with moderate to severe obstructive sleep apnea (OSA) (obstructive AHI (oAHI) ≥ 15/h)
  • BMI < 30 kg/m²
  • Age > 18 year
  • PSG < 2 years old with stable body weight (+/- 5 kg), no ENT surgery since most recent PSG and stable clinical condition
  • Normal clinical and radiological (incl. OPG), periodontal en temporomandibular joint examination
  • Subject is capable of giving informed consent
  • No documented abuses (alcohol, drugs, …)

Exclusion Criteria:

  • Edentulous patients
  • Insufficient teeth to support the mandibular advancement device
  • Active periodontal problems including tooth mobility
  • Active temporomandibular joint dysfunction
  • Limited maximum protrusive capacity (<6 mm)
  • Limited vertical opening (<25 mm)
  • Enlarged palatine tonsils (Grade IV tonsils)
  • Degenerative neuromuscular disorders
  • Pregnancy or willing to become pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716648


Contacts
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Contact: Marijke Dieltjens, PhD 003238215221 marijke.dieltjens@uza.be

Sponsors and Collaborators
University Hospital, Antwerp
Investigators
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Principal Investigator: Olivier Vanderveken, MD, PhD University Hospital, Antwerp

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ethisch Comité, UZA, prof. dr. Olivier Vanderveken, MD, PhD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03716648    
Other Study ID Numbers: 18/33/364
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases