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OpenTrials
Completed

NCT Number: NCT05805527

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

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.

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Key information

Conditions

Insomnia Disorder Disease Dyssomnias Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Bordeaux

Bordeaux, 33076, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older
  • Being able to communicate and read in French
  • Previous use a mobile phone

Exclusion criteria

  • N/A

Treatment and study plan

mobile health application named KANOPEE

Diagnostic Test

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

Primary outcomes

  1. Concurrent validity (sensitivity and specificity)

    Time frame: May-July 2023

    Calculated with a gold standard evaluation consisting of the clinical diagnosis of a clinician using a validated structured clinical interview for the DSM 5 criteria of insomnia disorder

Secondary outcomes

  1. Acceptability of the fully-automated interview

    Time frame: May-July 2023

    It will be measured with the Acceptability E-Scale (AES), that comprises six items and provides a total score as well as two subscores regarding usability (i.e. the perceived ease of using the system) and satisfaction with the system. Items are answered on a five-point Likert-type scale ranging from 1: Very unsatisfied, to 5: Very satisfied. Therefore, higher scores connote better acceptability.

  2. Perceptions of the virtual agent

    Time frame: May-July 2023

    It will be measured with the ECA-Trust Questionnaire (ETQ), that includes six items that are answered on a four-point Likert-type scale ranging from 0: Not at all, to 3: Totally agree. It provides a total score as well as subscores on two separate dimensions, named perceived credibility and perceived benevolence of the virtual agent conducting the digital interview. Higher scores connote more trust.

Sponsors and collaborators

Lead sponsor

University of Bordeaux

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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