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Hyoid Suspension to the Mandible for the Treatment of Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT02738112
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Abidin, Michael, M.D.

Brief Summary:

Hyo-mandibular suspension has been previously studied as a treatment for obstructive sleep apnea (OSA) and has shown to be highly effective.

This is a prospective, multi-center, registry during which 30 subjects with OSA will be considered for hyo-mandubular suspension treatment. After obtaining informed consent and meeting all inclusions and exclusion criteria, subjects will be treated using the Encore System. Subject follow-up with the physician or nurse will occur at one (1) week, one (1) month, three (3) months, and twelve (12) months.

This study will assess the effectiveness of hyoid suspension in reducing the apnea-hypopnea index (AHI), and improving the Epworth Sleepiness Scale (ESS), snoring (VAS) and functional outcome (FOSQ) for the treatment of obstructive sleep apnea (OSA). In addition, the study will evaluate the effect that the change in hyoid position has on the airway anatomy.


Condition or disease Intervention/treatment
Obstructive Sleep Apnea Device: Encore System

Detailed Description:

Obstructive sleep apnea (OSA) has become a major heath problem in the United States. With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure.

The first line and most common treatment for OSA is continuous positive airway pressure (CPAP) treatment, utilized by an estimated 3 million Americans. CPAP is effective in reducing the AHI if used properly. However, the nasal mask required for CPAP during sleep leads to poor acceptance and compliance rates. Published studies on CPAP have shown that only 58 to 80% of patients accept CPAP therapy,, and further 65 to 90% of these patients exhibit long-term compliance with CPAP. Additionally, there are many patients who would choose other therapy besides CPAP.

Patients cite a number of issues with CPAP, namely discomfort and inability to sleep while connected to an air pump. Auto-titrating CPAP, heated and humidified air, and bi-PAP (different pressures on inspiration and expiration) have improved patient compliance, but there remains a significant unmet clinical need.

It is widely accepted that the region behind the tongue is a major site of collapse during obstructive sleep apnea. In fact, there are many surgical procedures performed currently to address tongue base collapse. These include: RF ablation (Somnoplasty) of the tongue base; genioglossus advancement; Medtronic's Repose system for tongue base suspension; hyoid suspension; and maxillomandibular advancement (MMA). The change in airway dimension after MMA surgery on the lateral cephalograph is presented in Figure 1.

One of the principal mechanisms of effect of MMA surgery is to move the base of the tongue and the attached structures forward. Hyo-mandibular suspension has been previously studied as a treatment for OSA and has shown to be highly effective.

This is a prospective, multi-center, registry during which 30 subjects with OSA will be considered for hyo-mandubular suspension treatment. After obtaining informed consent and meeting all inclusions and exclusion criteria, subjects will be treated using the Encore System. Subject follow-up with the physician or nurse will occur at one (1) week, one (1) month, three (3) months, and twelve (12) months.

This study will assess the effectiveness of hyoid suspension in reducing the apnea-hypopnea index (AHI), and improving the Epworth Sleepiness Scale (ESS), snoring (VAS) and functional outcome (FOSQ) for the treatment of obstructive sleep apnea (OSA). In addition, the study will evaluate the effect that the change in hyoid position has on the airway anatomy.


Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hyoid Suspension to the Mandible for the Treatment of Obstructive Sleep Apnea
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea


Intervention Details:
  • Device: Encore System
    Hyo-mandibular suspension


Primary Outcome Measures :
  1. Apnea-Hypopnea Index (AHI) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Hyoid position and airway dimension measurement [ Time Frame: 3 months ]
  2. Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: 3 months ]
  3. Snoring Scale (Visual Acuity Scale) [ Time Frame: 3 months ]
  4. Epworth Sleeping Scale [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with obstructive sleep apnea (OSA) who meet the inclusion/exclusion criteria.
Criteria

Inclusion Criteria:

  1. Documented diagnosis of moderate or severe obstructive sleep apnea (AHI between 20 and 60/hour) evaluated with a sleep study within 12 months prior to the planned procedure
  2. Age ≥ 20 and ≤ 65 years old
  3. Body Mass Index (BMI) ≤ 36 (kg/m2)
  4. Patient has been offered CPAP and has refused or failed to continue CPAP treatment or is noncompliant with CPAP
  5. Significant airway narrowing while mild posterior is pressure applied to hyoid bone
  6. Evidence of hypopharyngeal obstruction via pharyngoscopy
  7. Signed informed consent to participate in this clinical study

Exclusion Criteria:

Patient History

  1. Prior OSA surgery (uvulopalatopharyngoplasty [UPPP], tonsillectomy and nasal surgery are acceptable)
  2. Active systemic infection
  3. Allergy to any medication used during implantation
  4. Previous history of neck or upper respiratory tract cancer
  5. Radiation therapy to neck or upper respiratory tract
  6. Significant dysphagia or speech disorder Anatomical Considerations

1. Identified obvious palatal stenosis 2. Enlarged tonsils (3+) 3. Anatomy unable to accommodate the implant

Other

  1. Other medical, social or psychological problems that, in the opinion of the investigator, preclude patient from receiving this treatment, as well as the procedures and evaluations pre- and post-treatment
  2. Enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study
  3. Unable and/or not willing to comply with treatment follow-up requirements
  4. Pregnancy (Female subjects of childbearing potential must have a negative pregnancy test prior to enrollment.)
  5. Lack of insurance coverage for procedure and PSG follow up and unwillingness to self pay
  6. Unwilling or unable to give signed informed consent

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): NCT02738112


Contacts
Contact: Dustin A Platter, B.S. 301-501-0752 dustin.platter1@gmail.com

Locations
United States, Virginia
Michael Abidin Recruiting
Alexandria, Virginia, United States, 22310
Contact: Dustin A Platter, BS    301-501-0752    dustin.platter1@gmail.com   
Sponsors and Collaborators
Abidin, Michael, M.D.
Investigators
Principal Investigator: Michael Abidin, MD Private practice

Responsible Party: Abidin, Michael, M.D.
ClinicalTrials.gov Identifier: NCT02738112     History of Changes
Other Study ID Numbers: HS 2016.0
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases