NCT07688603

Brief Summary

This study will compare the output of a new Level 3 polysomnography system against in-laboratory polysomnography.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Jun 2026Nov 2026

First Submitted

Initial submission to the registry

April 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

April 9, 2026

Last Update Submit

July 2, 2026

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (2)

  • Apneas

    Frequency of apneas (events per hour)

    1 night recording per test

  • Oxygen Saturation

    Oxygen saturation (%)

    1 Night recording per test

Study Arms (1)

Sleep Laboratory Patients

EXPERIMENTAL
Device: Comparison 1: Level 1 Polysomnography: Cadwell/AliceDevice: Comparison 2: Level 3 Test: Berry Sleep Apnea Screening Monitor

Interventions

Comparison 1: Level 1 Polysomnography: Cadwell/AliceDEVICE

Gold standard measurement of sleep to compare against.

Also known as: Cadwell, Alice
Sleep Laboratory Patients
Comparison 2: Level 3 Test: Berry Sleep Apnea Screening MonitorDEVICE

Novel Level 3 test under development.

Also known as: Berry Sleep Apnea Screening Monitor
Sleep Laboratory Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referred for a diagnostic sleep study

You may not qualify if:

  • under the age of 18
  • significant cardiopulmonary disease, neuromuscular disease or stroke
  • other significant sleep disorders
  • use of opiate medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

July 7, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

July 7, 2026

Record last verified: 2026-07