← Back to Search

Medical Device

Wesper Lab Home Test for Sleep Apnea in Children

N/A

Waitlist Available

Led By German P Digoy, M.D.

Research Sponsored by Tatch Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be 2 to 21 years of age

Must not have

Individuals younger than 2 years of age

Individuals older than 21 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is evaluating the effectiveness of a wireless home sleep test called Wesper Lab in diagnosing sleep apnea in children. The study aims to compare Wesper Lab with the standard overnight sleep test called

Who is the study for?

This trial is for children and young adults aged 2 to 21 who are already scheduled for a standard sleep study (PSG) to check for sleep apnea. Participants will use the Wesper Lab home test at the same time as their regular PSG.

What is being tested?

The study tests how well the Wesper Lab, a wireless home sleep test device, measures sleep apnea compared to traditional overnight polysomnography. It checks if both methods agree on the severity of sleep apnea in participants.

What are the potential side effects?

Since this trial involves non-invasive monitoring with Wesper Lab and an FDA approved pulse oximeter during a routine PSG, side effects are minimal but may include discomfort from wearing sensors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can sign the consent form myself, or if under 18, my guardian can.

Select...

I am between 2 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 2 years old.

Select...

I am over 21 years old.

Select...

I am a female aged 12 or older and have a positive pregnancy test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Agreement of Wesper Lab with Polysomnography (PSG) for the scoring of the apnea/hypopnea index (AHI).

Secondary study objectives

Agreement of Wesper Lab with Polysomnography (PSG) for the calculation of sleep apnea severity.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Medical Device: Wesper Lab (Single Arm)Experimental Treatment1 Intervention

Participants already undergoing a prescribed polysomnography (PSG) sleep study for the diagnosis of sleep apnea will be asked to simultaneously wear Wesper Lab, a home sleep test device.

0 / 5Eligibility criteria met