NCT05115305

Brief Summary

The Prodigy system, developed by Cerebra Medical Ltd, allows for the generation of the same information in the home that is currently only obtained in in-laboratory studies. The objective of the current study is to demonstrate that the signals obtained by this comprehensive, portable system are comparable to those obtained in in-laboratory studies.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

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

First Submitted

Initial submission to the registry

October 20, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 14, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

October 20, 2021

Last Update Submit

July 19, 2022

Conditions

Sleep Apnea

Keywords

Prodigy

Outcome Measures

Primary Outcomes (3)

  • Total Sleep Time

    To compare Level 1 and Level 2 sleep tests on TST

    Concurrent measurement for one night

  • Apnea-Hypopnea Index

    To compare Level 1 and Level 2 sleep tests on AHI

    Concurrent measurement for one night

  • Periodic Limb Movement Index

    To visually compare Level 1 and Level 2 sleep tests on PLM

    Concurrent measurement for one night

Secondary Outcomes (1)

  • Signal Quality

    Concurrent measurement for one night

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from patients referred to either sleep clinic to undergo a diagnostic sleep test.

You may qualify if:

  • patients undergoing a diagnostic sleep test

You may not qualify if:

  • in-hospital patients
  • subjects who self-report a previous diagnosis of neuromuscular disorders, obesity hypoventilation, or severe lung disease
  • subjects who are not fluent in English, or who have special communication needs
  • subjects who have dementia/Alzheimer's disease
  • subjects with comorbid violent parasomnias
  • subjects requiring additional assistance or who have limited ability follow commands.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Charles Sleep Disorders Center

Port Jefferson, New York, 11777, United States

Location

Hamilton Sleep Disorders Clinic

Hamilton, Ontario, L8P 4M3, Canada

Location

Related Publications (6)

  • Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

    PMID: 7726811BACKGROUND

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PMID: 2748771BACKGROUND

  • Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

    PMID: 21532953BACKGROUND

  • Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.

    PMID: 1798888BACKGROUND

  • Chasens ER, Ratcliffe SJ, Weaver TE. Development of the FOSQ-10: a short version of the Functional Outcomes of Sleep Questionnaire. Sleep. 2009 Jul;32(7):915-9. doi: 10.1093/sleep/32.7.915.

    PMID: 19639754BACKGROUND

  • Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

    PMID: 21479777BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Amy Bender, PhD

    Cerebra Medical

    PRINCIPAL INVESTIGATOR

  • Raymond Gottschalk, MD

    Hamilton Sleep Disorders Clinic

    PRINCIPAL INVESTIGATOR

  • Mohammad Amin, MD

    St Charles Sleep Disorders Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 10, 2021

Study Start

January 14, 2022

Primary Completion

April 9, 2022

Study Completion

April 9, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)CA(1)