Assessing the Performance of Wesper Lab for Sleep Apnea Diagnosis in Pediatric Populations

Sleep Apnea Clinical Trial

Official title:

A Single Arm Quantitative Study Assessing Performance of Wesper Lab as a Tool to Aid in Sleep Apnea Diagnosis in Pediatric Populations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06218186
• Other study ID #: WSP-111
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: Tatch Inc.
• Contact: Chelsie E Rohrscheib, Ph.D
• Phone: 18106236374
• Email: chelsie[@]wesper.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this single arm study is to evaluate the effectiveness of Wesper Lab, previously known as TatchSleep Pro, a wireless home sleep test, as a tool to aid in sleep apnea diagnosis as compared to an overnight polysomnography (PSG) evaluation in a pediatric population (subjects 2 to 21 years of age). The main question[s] it aims to answer are: - Does Wesper Lab demonstrate agreement with PSG for the calculation of the apnea/hypopnea index (AHI)? - Does Wesper Lab demonstrate agreement with PFG for the calculation of sleep apnea severity. Participants that are already undergoing a prescribed PSG for the detection of sleep apnea will be asked to simultaneously wear the Wesper Lab sensors and an FDA approved pulse oximeter. Researchers will compare the AHI of Wesper Lab to the AHI of the PSG to determine the accuracy of the Wesper Lab device. This is a single center, single-arm, quantitative study

Description:

This is a single center, single-arm, quantitative study evaluating the effectiveness of the Wesper Lab, previously known as TatchSleep Pro, wireless sensors as a tool to aid in sleep apnea diagnosis as compared to an overnight polysomnography (PSG) evaluation in a pediatric population. Investigators will identify approximately 150 eligible pediatric patients, 50 subjects per subgroup, who have been recommended to receive an overnight PSG for the detection/evaluation of sleep apnea. Subgroups include pediatric patients in the following age ranges: subgroup 1: 2-5 years old, subgroup 2: 6-11 years old, subgroup 3: 12-21 years old. After informed consent is obtained, a brief sleep-related medical history will be collected including relevant demographics. Females of childbearing potential (12 years or older) 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 Wesper Lab patches and an FDA-cleared pulse oximeter compatible with and connected to the Wesper Lab 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 Wesper Lab 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 Wesper Lab will be scored by an independent qualified sleep technologist (the primary reader) to yield an analysis of the accuracy of Wesper Lab compared with the PSG signals. At least one and up to two additional readers (secondary readers) will score only the Wesper Lab data to obtain an estimate of inter-rater reliability. Accuracy of the Wesper Lab device will be demonstrated by comparing the Pearson correlation of Wesper Lab and PSG AHI to a performance goal. The performance goal is based on a meta-analysis of FDA-cleared similar devices. Fisher's transformation and one-sided Z-test will be used to test the hypotheses with a significance level of 0.025. The upper and lower 95% Bland-Altman limits of agreement will be calculated and statistically compared using a Wald test to performance goals based on a meta-analysis of FDA-cleared similar devices. Deming regression will also be presented. The inter-rater reliability of Wesper Lab AHIs will be calculated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

Inclusion Criteria:

• Be 2 to 21 years of age.
• Have a referral to the study site from a physician to complete an overnight polysomnogram test for sleep apnea detection or follow-up.
• Be willing and able to wear two Wesper Lab patches and an FDA-cleared pulse oximeter in conjunction with a polysomnogram, for a single night.
• If 18 years or older, be able to willingly sign a written informed consent form prior to the initiation of any study procedure. If younger than 18 years of age, have a parent or legal guardian voluntarily willing to sign a written informed consent form prior to the initiation of any study procedures. Adult patients unable to provide written informed consent on their own behalf will not be eligible for the study.

Exclusion Criteria:

• Individuals younger than 2 years of age.
• Individuals older than 21 years of age
• Females 12 years or older who have a positive urine pregnancy test on the day of the study.
• Any known health condition that, in the opinion of the Investigator, would exclude the patient from participating in the study.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea Syndromes in Children
• Syndrome

Intervention

Device:
• Medical Device: Wesper Lab Home Sleep Test
Wesper Lab is a medical device that is used for the diagnosis of sleep apnea. Wesper lab is composed of two flexible biosensors that adhere to the abdomen and thorax with medical grade adhesive. A FDA approved pulse oximeter is worn on a finger.

Locations

Country	Name	City	State
United States	Summit Medical Center	Edmond	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Tatch Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Raphelson JR, Ahmed IM, Ancoli-Israel S, Ojile J, Pearson S, Bennett N, Uhles ML, Rohrscheib C, Malhotra A. Evaluation of a novel device to assess obstructive sleep apnea and body position. J Clin Sleep Med. 2023 Sep 1;19(9):1643-1649. doi: 10.5664/jcsm.1 — View Citation

Zandieh S, Kirschenbaum MA, Greenberg H, Ancoli-Israel S. Keep it simple: A novel technique for measuring airflow using a wireless patch. Sleep Health. 2023 Feb;9(1):100-107. doi: 10.1016/j.sleh.2022.10.005. Epub 2022 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement of Wesper Lab with Polysomnography (PSG) for the scoring of the apnea/hypopnea index (AHI).	The apnea/hypopnea index (AHI) is a measurement of the presence and seventy of sleep apnea. AHI is the average number of apneas and hypopnea per hour of recorded sleep time, as determined by the American Academy of Sleep Medicine.; The primary outcome measure of this study is to determine there is sufficient agreement between the AHI measured by Wesper Lab with the AHI measured by PSG.	8 hours
Secondary	Agreement of Wesper Lab with Polysomnography (PSG) for the calculation of sleep apnea severity.	The apnea/hypopnea index (AHI) is a measurement of the presence and seventy of sleep apnea. AHI is the average number of apneas and hypopnea per hour of recorded sleep time, as determined by the American Academy of Sleep Medicine.; Sleep apnea severity is calculated with AHI as determined by the American Academy of Sleep Medicine.; Normal: AHI = 0 - 4.99 Mild: AHI = 5 - 14.99 Moderate: AHI = 15 - 29.99 Severe: AHI = >30; The secondary outcome measure is to determine there is sufficient agreement between the sleep apnea severity measured by Wesper Lab with the sleep apnea severity measured by PSG.	8 hours

External Links

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