NCT06224972

Brief Summary

The study is a comparative, self-controlled, randomized, prospective investigation designed to assess the usability and accuracy of the DormoTech Vlab and compare its performance with a full polysomnography (PSG) study conducted over one night in a sleep lab. For the purpose of this study, the selected PSG device used for comparison is the Nox A1 system (K192469). Participants were required to wear the DormoTech Vlab, answer questionnaires pre and post-study, and simultaneously undergo a full PSG test using the Nox system. The statistical methodology for this study was designed to ensure a comprehensive analysis of the data, adhering to the standards set by the International Council for Harmonisation (ICH) E3 guideline

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

December 6, 2023

Last Update Submit

January 15, 2024

Conditions

Sleep Disorder

Keywords

Sleep testSleep disorderHome sleep testsPhysiological data recorderSleep diagnostics

Outcome Measures

Primary Outcomes (1)

  • AHI Score and Classification

    The AHI (apnea-hypopnea index) score was categorized and compared according to levels of severity: AHI = number of Apneas+Hypopneas/total sleep time Categorizing Normal \<5, Mild: 5\<AHI\<15, Moderate: 15\<AHI\<30, Severe: 30\<AHI

    During night 1

Secondary Outcomes (8)

  • Total Sleep Time (min)

    During night 1

  • Sleep Efficiency (%)

    During night 1

  • Sleep Stages (%)

    During night 1

  • Sleep Latency (min)

    During night 1

  • Wake After Sleep Onset (min)

    During night 1

  • +3 more secondary outcomes

Other Outcomes (2)

  • Usability Questionnaire

    During night 1

  • Safety Measures

    During night 1

Study Arms (1)

Observational group

The study is observational study - one group.

Device: Vlab

Interventions

VlabDEVICE

The study is observational, there is no intervention.

Observational group

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects were recruited in the sleep clinic by the attending physician, or sub-investigator. The participants were patients who were referred by physicians for a full sleep study at the sleep laboratory.

You may qualify if:

  • Age of 22 years old and above.
  • Willingness and ability to comply with the protocol requirements.
  • Understanding and provision of signed and dated informed consent

You may not qualify if:

  • Unwillingness to sign informed consent.
  • Age below 22 years.
  • Presence of implanted electronic devices or use of exterior electronic devices during the procedure.
  • Known allergies to device materials.
  • Skin irritation or open wounds at the device placement site.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shamir Medical Center

Be’er Ya‘aqov, Israel

Location

Related Publications (1)

  • Fox BD, Shihab M, Nassir A, Kushinsky D, Barnea O, Tal A. Validation of a novel mask-based device for monitoring of comprehensive sleep parameters and sleep disordered breathing. Sleep Breath. 2025 Jan 20;29(1):83. doi: 10.1007/s11325-025-03250-1.

    PMID: 39833613DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Benjamin D Fox, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

January 25, 2024

Study Start

June 13, 2023

Primary Completion

August 12, 2023

Study Completion

August 12, 2023

Last Updated

January 25, 2024

Record last verified: 2024-01

Locations

IL(1)