Trial Outcomes & Findings for Transcend Auto vs Commercially Available Device Clinical Evaluation for Treatment of Obstructive Sleep Apnea (OSA) (NCT NCT01799265)

Last Updated: 2025-01-13

Results Overview

Apnea hypopnea index (AHI) will be measured during treatment with each of the devices. AHI = (number of apneas + number of hypopneas) / total sleep time in hours. The minimum score is zero. The higher the score, the more severe the sleep apnea. For example, obstructive sleep apnea is defined as an AHI \>/= 15. AHI was measured by the devices and independently by a central laboratory.

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

first and second night sleep study

Results posted on

2025-01-13

Participant Flow

Sites screened individuals who were appropriate for study inclusion by chart review followed by telephone interview. Patients were then asked to schedule an office visit. If the screened individual met the selection criteria, and was interested in participation, the subject was asked to provide informed consent for participation. Subjects were considered enrolled in the study at the time of consent.

Participant milestones

Participant milestones
Measure	Transcend Auto Then REMstar Auto Patients underwent first night sleep study with Transcend followed by second night sleep study with REMstar	REMStar Then Transcend Auto Patients underwent first night sleep study with REMStar and second night with Transcend Auto
Overall Study STARTED	20	21
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Transcend Auto Then REMstar Auto Patients underwent first night sleep study with Transcend followed by second night sleep study with REMstar	REMStar Then Transcend Auto Patients underwent first night sleep study with REMStar and second night with Transcend Auto
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	2	1
Overall Study inadequate sleep study	0	2

Baseline Characteristics

Transcend Auto vs Commercially Available Device Clinical Evaluation for Treatment of Obstructive Sleep Apnea (OSA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=41 Participants Baseline characteristics were collected for all patients and were not analyzed by treatment arm
Age, Continuous	51 Years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants

PRIMARY outcome

Timeframe: first and second night sleep study

Outcome measures

Outcome measures
Measure	Transcend n=35 Participants This is the result when treated with Transcend	REMStar n=35 Participants This is the result when treated with REMStar
Mean Apnea Hypopnea Index (AHI) During Treatment	2.1 AHI Standard Deviation 2.0	2.0 AHI Standard Deviation 2.4

SECONDARY outcome

Timeframe: first and second night sleep study

Patients will be monitored for unanticipated adverse device effects during each sleep study. Patients will not be followed after the second sleep study.

Outcome measures

Outcome measures
Measure	Transcend n=35 Participants This is the result when treated with Transcend	REMStar n=35 Participants This is the result when treated with REMStar
Unanticipated Adverse Device Effects	0 Participants	0 Participants

SECONDARY outcome

Timeframe: first and second night sleep study

Population: Hypopnea index (HI)

Mean hypopnea index will be measure during treatment. HI will be measured during treatment with each of the devices. HI = number of hypopneas / total sleep time in hours. The minimum score is zero. The higher the score, the more severe the sleep apnea. For example, obstructive sleep apnea is defined as an AHI \>/= 15. HI was measured by the devices and independently by a central laboratory. Results are reported as the Mean Differences between PSG and Device Hypopnea Index. These differences can be reported as negative values.

Outcome measures

Outcome measures
Measure	Transcend n=35 Participants This is the result when treated with Transcend	REMStar n=35 Participants This is the result when treated with REMStar
Mean Differences Between Polysomnography (PSG) and Device Measures of Apnea Index (AI) and Hypopnea Index (HI)	-0.7 units on a scale Standard Deviation 2.3	0.2 units on a scale Standard Deviation 1.6

Adverse Events

Transcend

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

REMStar

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Transcend n=20 participants at risk Transcend Arm	REMStar n=21 participants at risk REMStar Arm
General disorders headache	5.0% 1/20 • Number of events 1 • Patients were not followed after the second sleep study. Documentation of adverse events stopped after the second night's sleep study. Low level headache-lightheaded.	0.00% 0/21 • Patients were not followed after the second sleep study. Documentation of adverse events stopped after the second night's sleep study. Low level headache-lightheaded.

Additional Information

Melinda Swanson

Bluebird Consulting

Phone: 6123084500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60