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

NCT02738112 | Unknown

• 1 other identifier: HS 2016.0
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea Index (AHI)

  3 months

Secondary Outcomes (4)

• Hyoid position and airway dimension measurement

  3 months

• Functional Outcomes of Sleep Questionnaire (FOSQ)

  3 months

• Snoring Scale (Visual Acuity Scale)

  3 months

• Epworth Sleeping Scale

  3 months

Interventions

Encore System DEVICE

Hyo-mandibular suspension

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with obstructive sleep apnea (OSA) who meet the inclusion/exclusion criteria.

You may qualify if:

• 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
• Age ≥ 20 and ≤ 65 years old
• Body Mass Index (BMI) ≤ 36 (kg/m2)
• Patient has been offered CPAP and has refused or failed to continue CPAP treatment or is noncompliant with CPAP
• Significant airway narrowing while mild posterior is pressure applied to hyoid bone
• Evidence of hypopharyngeal obstruction via pharyngoscopy
• Signed informed consent to participate in this clinical study

You may not qualify if:

• Patient History
• Prior OSA surgery (uvulopalatopharyngoplasty \[UPPP\], tonsillectomy and nasal surgery are acceptable)
• Active systemic infection
• Allergy to any medication used during implantation
• Previous history of neck or upper respiratory tract cancer
• Radiation therapy to neck or upper respiratory tract
• Significant dysphagia or speech disorder Anatomical Considerations
• \. Identified obvious palatal stenosis 2. Enlarged tonsils (3+) 3. Anatomy unable to accommodate the implant
• Other
• 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
• Enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study
• Unable and/or not willing to comply with treatment follow-up requirements
• Pregnancy (Female subjects of childbearing potential must have a negative pregnancy test prior to enrollment.)
• Lack of insurance coverage for procedure and PSG follow up and unwillingness to self pay
• Unwilling or unable to give signed informed consent

Sponsors & Collaborators

• Abidin, Michael, M.D.: lead

Study Sites (1)

Michael Abidin

Alexandria, Virginia, 22310, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Abidin, MD

  Private Practice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dustin A Platter, B.S.

CONTACT

301-501-0752; dustin.platter1@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 27, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)