NCT06038006

Brief Summary

This study compares the diagnostic capability of a millimeter-wave radar-based Sleep Respiratory Monitoring System to the gold standard polysomnography.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 13, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

September 8, 2023

Last Update Submit

September 8, 2023

Conditions

Sleep Breathing Disorders

Outcome Measures

Primary Outcomes (6)

  • Diagnostic Sensitivity (AHI≥5) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)

    The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 5 events per hour according to SRMS in participants with AHI ≥ 5 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic sensitivity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.

    Day 1

  • Diagnostic Sensitivity (AHI≥15) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)

    The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 15 events per hour according to SRMS in participants with AHI ≥ 15 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic sensitivity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.

    Day 1

  • Diagnostic Sensitivity (AHI≥30) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)

    The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 30 events per hour according to SRMS in participants with AHI ≥ 30 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic sensitivity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.

    Day 1

  • Diagnostic Specificity (AHI≥5) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)

    The proportion of participants with Apnea Hypopnea Index (AHI) \< 5 events per hour according to SRMS in participants with AHI \< 5 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic specificity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.

    Day 1

  • Diagnostic Specificity (AHI≥15) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)

    The proportion of participants with Apnea Hypopnea Index (AHI) \< 15 events per hour according to SRMS in participants with AHI \< 15 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic specificity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.

    Day 1

  • Diagnostic Specificity (AHI≥30) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)

    The proportion of participants with Apnea Hypopnea Index (AHI) \< 30 events per hour according to SRMS in participants with AHI \< 30 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic specificity of SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.

    Day 1

Secondary Outcomes (5)

  • Intra-Class Correlation Coefficient (ICC) of Apnea Hypopnea Index (AHI)

    Day 1

  • Intra-Class Correlation Coefficient (ICC) of Total Sleep Time (TST)

    Day 1

  • Intra-Class Correlation Coefficient (ICC) of Deep Sleep Proportion

    Day 1

  • Intra-Class Correlation Coefficient (ICC) of Light Sleep Proportion

    Day 1

  • Intra-Class Correlation Coefficient (ICC) of Rapid Eye Movement (REM) Sleep Proportion

    Day 1

Study Arms (1)

Participants

EXPERIMENTAL

The only arm containing participants of this study.

Diagnostic Test: Sleep Respiratory Monitoring System

Interventions

Sleep Respiratory Monitoring SystemDIAGNOSTIC_TEST

Millimeter-Wave radar-based Sleep Respiratory Monitoring System to be used on each participant undergoing PSG

Participants

Eligibility Criteria

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

You may qualify if:

  • Participants is 18 years of age or older.
  • Participants is willing to undergo overnight polysomnography and Sleep Respiratory Monitoring System testing.

You may not qualify if:

  • Participants with severe cardiovascular and cerebrovascular diseases, severe liver, kidney, and lung dysfunction.
  • Participants with unstable respiratory diseases, or other diseases in acute phase.
  • Long-term or current use of barbiturates, benzodiazepines, sedatives and other drugs that may affect sleep.
  • Participants that undergo CPAP treatment during the night of the trial.
  • Participants with other sleep disorders, e.g. insomnia.
  • Participants with mental disorders.
  • Participants that refuse to sign informed consents.
  • Participants unable to cooperate with medical examination.
  • Participants excluded in the opinion of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (1)

  • Li CY, Wang W, Huang WJ, Xu HH, Yi HL, Guan J, Li G, Yin SK. [Diagnosis of obstructive sleep apnea by a new radar device: a parallel controlled study evaluating agreement with polysomnographic monitoring]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2024 Aug 7;59(8):857-863. doi: 10.3760/cma.j.cn115330-20231204-00267. Chinese.

    PMID: 39193596DERIVED

Study Officials

  • Shankai Yin

    Shanghai 6th People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Guan

CONTACT

18930172210guanjian0606@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
During this study, results of the radar-based Sleep Respiratory Monitoring System are not known by the investigator and outcomes assessor, including the personnel who scores PSG.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 14, 2023

Study Start

July 13, 2023

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

CN(1)