Trial Outcomes & Findings for FAST as a Treatment for Obstructive Sleep Apnea (NCT NCT01611779)

Results Overview

Ability to place the implant and stabilize the tongue

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

Up to 7 weeks after the procedure

Results posted on

2017-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	Tongue Suspension Tongue-based suspension Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FAST as a Treatment for Obstructive Sleep Apnea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tongue Suspension n=5 Participants Tongue-based suspension Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Gender Female	1 Participants n=5 Participants
Gender Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Body Mass Index (BMI)	26.98 kg/m^2 STANDARD_DEVIATION 3.78 • n=5 Participants
Prior OSA Surgery	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 weeks after the procedure

Ability to place the implant and stabilize the tongue

Outcome measures

Outcome measures
Measure	Tongue Suspension n=5 Participants Tongue-based suspension Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
Place the Implant and Stabilize the Tongue	5 Participants

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Tongue Suspension n=5 Participants Tongue-based suspension Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
Number of Participants Experiencing Complications Headache	1 Participants
Number of Participants Experiencing Complications No Complications	4 Participants

SECONDARY outcome

Timeframe: Baseline, 3, and 12 months

Population: Three (3) of 5 subjects returned for 3 month follow-up and 2 of 5 subjects returned for the 12 month follow-up.

0 to \>30/hour (high value represents worse outcome)

Outcome measures

Outcome measures
Measure	Tongue Suspension n=5 Participants Tongue-based suspension Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
Apnea Hypopnea Index Baseline	24.2 events/hour Standard Deviation 10.3
Apnea Hypopnea Index 3 months	15.9 events/hour Standard Deviation 7.8
Apnea Hypopnea Index 12 months	34.6 events/hour Standard Deviation 6.6

SECONDARY outcome

Timeframe: Baseline, 1, 3, 12 months

Population: Four (4) of 5 total subjects had data at baseline and follow-up data.

Questionnaire: 0 to 120 (high value represents better outcome)

Outcome measures

Outcome measures
Measure	Tongue Suspension n=4 Participants Tongue-based suspension Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
Functional Outcomes and Sleep Questionnaire (FOSQ) Baseline	17.2 units on a scale Standard Deviation 1.6
Functional Outcomes and Sleep Questionnaire (FOSQ) 1 month	18.2 units on a scale Standard Deviation 1.9
Functional Outcomes and Sleep Questionnaire (FOSQ) 3 months	18.1 units on a scale Standard Deviation 2.1
Functional Outcomes and Sleep Questionnaire (FOSQ) 12 months	17.2 units on a scale Standard Deviation 2.4

SECONDARY outcome

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

Population: Four (4) of 5 total subjects had data at baseline. Four (4) of 5 subjects had follow-up data at 1 week, 4 had follow-up data at 1 month, 3 had follow-up data at 3 months, and 2 had follow-up data at 12 months.

0 to 10 (high value represents worse outcome)

Outcome measures

Outcome measures
Measure	Tongue Suspension n=4 Participants Tongue-based suspension Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
Snoring Scale (VAS) Baseline	5.5 units on a scale Standard Deviation 3.4
Snoring Scale (VAS) 1 week	2.6 units on a scale Standard Deviation 2.3
Snoring Scale (VAS) 1 month	1.8 units on a scale Standard Deviation 1.0
Snoring Scale (VAS) 3 months	1.8 units on a scale Standard Deviation 1.6
Snoring Scale (VAS) 12 months	1.7 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline, 1, 3, 12 months

Population: Five (5) of 5 total subjects had data at baseline. Four (4) of 5 subjects had follow-up data at 1 week, 4 had follow-up data at 1 month, 4 had follow-up data at 3 months, and 2 had follow-up data at 12 months.

0 to 24 (high value represents worse outcome)

Outcome measures

Outcome measures
Measure	Tongue Suspension n=5 Participants Tongue-based suspension Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
Epworth Sleeping Scale (ESS) Baseline	12.4 units on a scale Standard Deviation 4.0
Epworth Sleeping Scale (ESS) 1 month	7.7 units on a scale Standard Deviation 2.2
Epworth Sleeping Scale (ESS) 3 months	7 units on a scale Standard Deviation 2.4
Epworth Sleeping Scale (ESS) 12 months	6.5 units on a scale Standard Deviation 2.1

Adverse Events

Tongue Suspension

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tongue Suspension n=5 participants at risk Tongue-based suspension Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
General disorders Headache	20.0% 1/5 • Number of events 1 • 1 year

Additional Information

Michael Kolber

Siesta Medical, Inc.

Phone: 408-320-9424

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place