Level 3 Validation Study

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

About this study

Official title: Comparison of Home Level 3 Polysomnography to In-Laboratory Polysomnography

Conditions

Obstructive Sleep Apnea (OSA)

Being tested

Comparison 1: Level 1 Polysomnography: Cadwell/Alice, Comparison 2: Level 3 Test: Berry Sleep Apnea Screening Monitor

Medical subject headings

Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Comparison 1: Level 1 Polysomnography: Cadwell/AliceDevice

  Also called Cadwell, Alice

  Gold standard measurement of sleep to compare against.

• Comparison 2: Level 3 Test: Berry Sleep Apnea Screening MonitorDevice

  Also called Berry Sleep Apnea Screening Monitor

  Novel Level 3 test under development.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Apneas

   Frequency of apneas (events per hour)

   Measured: 1 night recording per test

2. Oxygen Saturation

   Oxygen saturation (%)

   Measured: 1 Night recording per test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted7 Jul 2026
2. Study startJun 2026 (estimated)
3. Primary completionNov 2026 (estimated)
4. Study completionNov 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.