NCT01611779

Brief Summary

The objective of this study is to assess the feasibility and safety of tongue suspension using the Siesta Medical Encore Tongue Suspension System for the treatment of obstructive sleep apnea (OSA).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

January 6, 2017

Completed
Last Updated

February 24, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

May 29, 2012

Results QC Date

November 9, 2016

Last Update Submit

January 10, 2017

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apneatongue suspension

Outcome Measures

Primary Outcomes (2)

  • Place the Implant and Stabilize the Tongue

    Ability to place the implant and stabilize the tongue

    Up to 7 weeks after the procedure

  • Number of Participants Experiencing Complications

    Patient will be examined by the investigator at each of the follow-up visits for the presence of any untoward or unintended response to the device.

    3 months

Secondary Outcomes (4)

  • Apnea Hypopnea Index

    Baseline, 3, and 12 months

  • Functional Outcomes and Sleep Questionnaire (FOSQ)

    Baseline, 1, 3, 12 months

  • Snoring Scale (VAS)

    Baseline, 1 week; 1 month, 3 months, 12 months

  • Epworth Sleeping Scale (ESS)

    Baseline, 1, 3, 12 months

Study Arms (1)

Tongue suspension

EXPERIMENTAL

Tongue-based suspension

Device: Encore Tongue Suspension System

Interventions

Encore Tongue Suspension SystemDEVICE

The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.

Also known as: Tongue suspension, FG0002
Tongue suspension

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented diagnosis of moderate obstructive sleep apnea (AHI 5-30/hour) measured within 12 months prior to the planned procedure
  • Age \>/= 20 and \>/= 65
  • Body Mass Index ,/= 32 (kg/m\^2)
  • Patient offered CPAP and has refused of failed to continue CPAP treatment or is not compliant with CPAP
  • Signed informed consent to participate in this study

You may not qualify if:

  • Prior OSA surgery
  • Active systemic infection
  • Allergy to any medication used during implantation
  • Previous history of neck or upper respiratory tract
  • Significant dysphagia or speech disorder
  • Anatomical
  • Identified obvious palatal stenosis
  • Enlarged tonsils (3+)
  • Anatomy unable to accommodate the implant
  • Other
  • Other medical, social, or psychological problems that , in the opinion of the investigator, precludes the patient from receiving this treatment and 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Atlanta Snoring and Sleep Disorders Institute

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Michael Kolber
Organization
Siesta Medical, Inc.
mkolber@siestamedical.com
408-320-9424

Study Officials

  • Andrew Goldberg, MD

    University of California, San Francisco

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2012

First Posted

June 5, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 24, 2017

Results First Posted

January 6, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)