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Evaluating the Validity and Acceptability of a Fully-automated Interview to Diagnose Insomnia Disorder: a Pilot Study

NCT05805527 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2023-12-05

No results posted yet for this study

Summary

Objective: to evaluate if a fully-automated diagnostic interview for insomnia disorder is suitable for clinical and research purposes (adequate sensitivity and specificity) and is acceptable to patients.

Study main outcomes:

1. Concurrent validity (sensitivity and specificity) compared to a gold standard. Gold standard: clinical diagnosis of a clinician using a validated structured clinical interview for the DSM 5 criteria of insomnia disorder
2. Acceptability of the fully-automated interview.

Participants:

Volunteers to undergo the clinical and the automated interview will be recruited through non-probability convenience sampling from patients attending the sleep clinic at Bordeaux University Hospital between May 2023 and July 2023.

Conditions

  • Insomnia Disorder

Interventions

DIAGNOSTIC_TEST

mobile health application named KANOPEE

Volunteers will undergo two clinical interviews, an in person clinician-led interview and a fully-automated interview administered via mobile phone

Sponsors & Collaborators

  • University of Bordeaux

    lead OTHER

Principal Investigators

  • Maria M Sanchez Ortuno, PhD · Universite de Bordeaux, France - Universidad de Murcia, Spain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-07-31
Completion
2023-08-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05805527 on ClinicalTrials.gov