NCT04419714

TatchSleep as a Tool to Aid in Sleep Apnea Analysis

A Single Center, Single Arm, Quantitative Study Assessing Performance of TatchSleep as a Tool to Aid in Sleep Apnea Analysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Wesper Inc · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

This is a single center, single-arm, quantitative study evaluating the efficacy of the TatchSleep wireless sensor patches as a tool to aid in sleep apnea analysis as compared to an overnight PSG evaluation.

Detailed description

This is a multi-center, single-arm, quantitative study evaluating the effectiveness of the TatchSleep Pro wireless sensors as a tool to aid in sleep apnea diagnosis as compared to an overnight PSG evaluation. Investigators will identify approximately 50 eligible patients who have been recommended to receive an overnight PSG for the detection/evaluation of sleep apnea. After informed consent is obtained, a brief sleep-related medical history will be collected including relevant demographics. Females of childbearing potential will be asked to undergo a urine dipstick pregnancy test to determine their eligibility for inclusion in the study. Patients will undergo their PSG test while simultaneously wearing 2 TatchSleep Pro patches and an FDA-cleared pulse oximeter compatible with and connected to the TatchSleep Pro system for a single night at the clinic. The same make and model of pulse oximeter will be used for all subjects. Patients will be observed overnight by trained sleep technicians who will setup the TatchSleep Pro device and collect the sleep data via the companion smartphone application. A follow-up communication will be made with patients within 5 days after the sleep study to assess any adverse events. Following the data collection, sleep data from PSG and TatchSleep Pro will be scored by an independent qualified sleep technologist (the primary reader) to yield an analysis of the accuracy of TatchSleep Pro compared with the PSG signals. At least one and up to two additional readers (secondary readers) will score only the TatchSleep Pro data to obtain an estimate of inter-rater reliability.

Conditions

• Sleep Apnea
• Sleep Disorder

Interventions

Type	Name	Description
DEVICE	TatchSleep	Wearable measurement device

Timeline

• Start date: 2021-06-10
• Primary completion: 2021-11-04
• Completion: 2021-11-04
• First posted: 2020-06-05
• Last updated: 2025-08-20
• Results posted: 2025-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study