Trial Outcomes & Findings for Validation of Sleep Apnea Screening Device (NCT NCT02814227)

NCT ID: NCT02814227

Last Updated: 2023-01-30

Results Overview

Specificity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: 8 hours
• Results posted on: 2023-01-30

Participant Flow

Participant milestones

Measure	Zansors® Sleep Screening Device Zansors device compared to overnight polysomnography Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography
Overall Study STARTED	52
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validation of Sleep Apnea Screening Device

Baseline characteristics by cohort

Measure	Zansors® Sleep Screening Device n=52 Participants Zansors device compared to overnight polysomnography Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography
Age, Continuous	47.8 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 hours

Specificity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals

Outcome measures

Measure	Zansors® Sleep Screening Device n=52 Participants Zansors device compared to overnight polysomnography Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography
Specificity	71.4 percentage of true negatives

SECONDARY outcome

Timeframe: 8 hours

Sensitivity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals

Outcome measures

Measure	Zansors® Sleep Screening Device n=52 Participants Zansors device compared to overnight polysomnography Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography
Sensitivity	75 percentage of true positives

SECONDARY outcome

Timeframe: 8 hours

PPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals

Outcome measures

Measure	Zansors® Sleep Screening Device n=52 Participants Zansors device compared to overnight polysomnography Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography
Positive Predictive Value (PPV)	0.692 positive predictive value

SECONDARY outcome

Timeframe: 8 hours

NPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals

Outcome measures

Measure	Zansors® Sleep Screening Device n=52 Participants Zansors device compared to overnight polysomnography Zansors® sleep screening device: Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography
Negative Predictive Value (NPV)	0.77 negative predictive value

Adverse Events

Zansors® Sleep Screening Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

J. Todd Arnedt, PhD

University of Michigan

Phone: 734-615-8666

Email: tarnedt@med.umich.edu

Results disclosure agreements

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