Trial Outcomes & Findings for Study of a Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (NCT NCT01146782)

NCT ID: NCT01146782

Last Updated: 2014-06-30

Results Overview

Comparing first treatment night AHI to control/baseline night. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and \>30/hr = severe OSA. For each subject, Clinical success was defined as apnea-hypopnea index (AHI) reduction of \>50% and treated AHI\<20. The number of subjects with clinical success was determined to calculate the primary endpoint as the ratio of the number of subjects with clinical success to the number of subjects.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 367 participants
• Primary outcome timeframe: first treatment night
• Results posted on: 2014-06-30

Participant Flow

Subjects for the study were recruited from the Investigator's sleep clinic or through advertising. Advertisements were approved by the applicable Institutional Review Board (IRB) prior to use.

Initial screening phase consisted of initial medical/dental and eligibility screening. Subjects then underwent an Oxygen Desaturation Index (ODI) screening (confirming ODI of 10-60) and one night of home use with the study device to screen for proper fit.

Participant milestones

Measure	Sleep Apnea Treatment (Primary Endpoint Cohort) The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) polysomnogram (PSG).
Screening Cohort STARTED	367
Screening Cohort COMPLETED	146
Screening Cohort NOT COMPLETED	221
Safety Cohort STARTED	146
Safety Cohort COMPLETED	63
Safety Cohort NOT COMPLETED	83
Primary Endpoint Cohort STARTED	63
Primary Endpoint Cohort COMPLETED	57
Primary Endpoint Cohort NOT COMPLETED	6

Reasons for withdrawal

Measure	Sleep Apnea Treatment (Primary Endpoint Cohort) The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) polysomnogram (PSG).
Screening Cohort Screen Failure	187
Screening Cohort Lost to Follow-up	4
Screening Cohort Physician Decision	1
Screening Cohort Withdrawal by Subject	29
Safety Cohort Screen Failure	61
Safety Cohort Withdrawal by Subject	4
Safety Cohort Control AHI <5	4
Safety Cohort TST <4 hrs	14
Primary Endpoint Cohort Withdrawal by Subject	5
Primary Endpoint Cohort Physician Decision	1

Baseline Characteristics

Study of a Sleep Apnea System for the Treatment of Obstructive Sleep Apnea

Baseline characteristics by cohort

Measure	Safety Cohort n=146 Participants Demographics and Baseline Characteristics are presented for the Safety Cohort (N=146)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	130 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Age, Continuous	53.2 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants
Region of Enrollment United States	146 participants n=5 Participants

PRIMARY outcome

Timeframe: first treatment night

Population: All subjects in the primary endpoint cohort were analyzed.

Comparing first treatment night AHI to control/baseline night. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. For each subject, Clinical success was defined as apnea-hypopnea index (AHI) reduction of >50% and treated AHI<20. The number of subjects with clinical success was determined to calculate the primary endpoint as the ratio of the number of subjects with clinical success to the number of subjects.

Outcome measures

Measure	Primary Endpoint Cohort n=63 Participants The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20	26 subjects with clinical success

SECONDARY outcome

Timeframe: 4 weeks

Population: The Safety Cohort consisted of all subjects who participated in at-home use of the device.

Further categorized as serious and non-serious, device-related and non-device-related, unanticipated and anticipated, and based on level of severity. Adverse events will be evaluated during the trial at the following visits during 28-day take-home period: 7-day, 14-day, 21-day, 28-day follow-up, and any unscheduled visits.

Outcome measures

Measure	Primary Endpoint Cohort n=146 Participants The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
Adverse Event Rate Unanticipated Adverse Events	0 subjects
Adverse Event Rate All adverse events	87 subjects
Adverse Event Rate Device related AEs categorized as moderate	15 subjects
Adverse Event Rate Device related AEs categorized as severe	0 subjects
Adverse Event Rate Device related adverse events	80 subjects
Adverse Event Rate Device related AEs categorized as mild	65 subjects
Adverse Event Rate Serious adverse events	0 subjects

SECONDARY outcome

Timeframe: At completion of 28 day home use.

Population: All subjects in primary endpoint cohort with final evaluable treatment PSG.

Comparing AHI at the last treatment night to the control/baseline night is reported as the percent change in AHI. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. Negative numbers represent a decrease/improvement in AHI, whereas positive numbers represent an increase/no improvement in AHI.

Outcome measures

Measure	Primary Endpoint Cohort n=52 Participants The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
Last Treatment Night Response (AHI Reduction)	-43.2 AHI reduction (% change) Interval -71.7 to 15.9

SECONDARY outcome

Timeframe: First treatment night

Comparing first treatment night to control/baseline night reported as percent change. Negative numbers represent a reduction/improvement in ODI, whereas positive numbers represent increases/no improvement in ODI.

Outcome measures

Measure	Primary Endpoint Cohort n=63 Participants The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
Percent Reduction in Oxygen Desaturation Index (ODI)	-41.9 ODI reduction (% change) Interval -63.5 to 9.5

Adverse Events

Safety Cohort

Serious events: 0 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Safety Cohort n=146 participants at risk Device related adverse events are presented for the Safety Cohort.
Skin and subcutaneous tissue disorders Oral Tissue Discomfort	47.9% 70/146 • Adverse events were collect at screening, control and treatment PSG, 7 days, 14 days, 21 days, 28 days and after the final treatment PSG.
Skin and subcutaneous tissue disorders Oral Tissue Irritation	18.5% 27/146 • Adverse events were collect at screening, control and treatment PSG, 7 days, 14 days, 21 days, 28 days and after the final treatment PSG.
General disorders Occlusal Change	0.68% 1/146 • Adverse events were collect at screening, control and treatment PSG, 7 days, 14 days, 21 days, 28 days and after the final treatment PSG.
General disorders Dental Discomfort	13.0% 19/146 • Adverse events were collect at screening, control and treatment PSG, 7 days, 14 days, 21 days, 28 days and after the final treatment PSG.
General disorders Excessive Salivation	2.1% 3/146 • Adverse events were collect at screening, control and treatment PSG, 7 days, 14 days, 21 days, 28 days and after the final treatment PSG.
General disorders Other Adverse Event	14.4% 21/146 • Adverse events were collect at screening, control and treatment PSG, 7 days, 14 days, 21 days, 28 days and after the final treatment PSG.

Additional Information

Andrea Brown, Director, Clinical Affairs

ApniCure, Inc.

Phone: 650-361-9000

Email: abrown@apnicure.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place