Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea

NCT07095413 | Not Yet Recruiting

• 1 other identifier: WSP-222
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of the Wesper Lab home sleep apnea test as a tool to aid in the diagnosis of sleep apnea in adult patients (age ≥21 years) who are recommended for an overnight polysomnography (PSG) evaluation. The main questions it aims to answer are:

1. 1.Is Wesper Lab home sleep apnea test as accurate as an in-laboratory sleep study (polysomnography) for the diagnosis of obstructive and central sleep apnea?
2. 2.Is Wesper Lab accurate in a wide range of body types and skin types?
3. 3.Provide informed consent and complete a brief medical history.
4. 4.Undergo an overnight polysomnography sleep study while wearing two Wesper Lab patches and a compatible pulse oximeter.
5. 5.Have a follow-up communication within 5 days post-study to assess any adverse events.

Conditions

Sleep Apnea; Sleep Apnea, Obstructive; Sleep Apnea, Central

Outcome Measures

Primary Outcomes (2)

• Correlation of the Apnea/Hypopnea Index Between Wesper Lab Sensors and PSG

  The primary outcome measure is to assess the correlation between the apnea-hypopnea index (AHI) and obtained from the Wesper Lab wireless sensors and those derived from the polysomnography (PSG) recordings.

  8 Hours

• Correlation of the Central Apnea/Hypopnea Index Between Wesper Lab Sensors and PSG

  The primary outcome measure is to assess the correlation between the apnea-hypopnea index (CAHI) and obtained from the Wesper Lab wireless sensors and those derived from the polysomnography (PSG) recordings.

  8 Hours

Secondary Outcomes (6)

• Inter-Rater Reliability

  8 Hours

• Agreement in Apnea Classification

  8 Hours

• Classification of Apnea Type

  8 hours

• Agreement in Respiratory Event Detection by Optical Sensors - AHI

  8 Hours

• Agreement in Total Sleep Time by Optical Sensors

  8 Hours

Study Arms (1)

Medical Device: Wesper Lab Home Sleep Apnea Test

OTHER

This arm consists of participants who will undergo an overnight polysomnography (PSG) evaluation while simultaneously wearing the Wesper Lab home sleep apnea tests.

Diagnostic Test: Wesper Lab Home Sleep Apnea Test

Interventions

Wesper Lab Home Sleep Apnea Test DIAGNOSTIC_TEST

Subjects will wear the Wesper Lab home sleep apnea tests, which includes 2 wireless sensors and a pulse oximeter.

Medical Device: Wesper Lab Home Sleep Apnea Test

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 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.
• Be able and 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.

You may not qualify if:

• Women who are pregnant, trying to get pregnant or who have a positive urine pregnancy test on the day of the study.
• Women who are breast-feeding
• History of severe insomnia
• Any known health condition that, in the opinion of the Investigator, would exclude the patient from participating in the study.

Sponsors & Collaborators

• Wesper Inc: lead

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Chelsie E Rohrscheib, Ph.D

  Attend a workshop

  STUDY DIRECTOR

• Ruchir P Patel, M.D.

  The Insomnia and Sleep Institute of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chelsie E Rohrscheib, Ph.D

CONTACT

8106236374; chelsie@wesper.co

Amir Reuveny, Ph.D

CONTACT

amir@wesper.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: A blinding model will be implemented for the scoring of the Wesper Lab data and Polysomnography (PSG) to minimize bias during the scoring and analysis of sleep study data. All sleep study recordings are disidentified before being presented to the readers. The primary reader and any additional secondary readers will be blinded to which device was used to collect the data (Wesper Lab vs. PSG). Studies will be reviewed in a predetermined randomized order to further prevent any bias. All data will be presented using the same viewing and scoring platform, ensuring consistency in how the data is labeled and displayed.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will wear the Wesper Lab sensors while undergoing the Polysomnography (PSG) test. The study focuses on evaluating the performance of the Wesper Lab sensors in the context of standard PSG without a separate control or comparison group.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 31, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share