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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05805527
Enrollment
56
Registered
2023-04-10
Start date
2023-05-01
Completion date
2023-08-30
Last updated
2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia Disorder

Keywords

Insomnia Disorder, Mobile health, Diagnosis

Brief 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.

Interventions

DIAGNOSTIC_TESTmobile 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

University of Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Concurrent validity (sensitivity and specificity)May-July 2023Calculated 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

MeasureTime frameDescription
Acceptability of the fully-automated interviewMay-July 2023It 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.
Perceptions of the virtual agentMay-July 2023It 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026