NCT05805527

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: University of Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-07-31
• Completion: 2023-08-30
• First posted: 2023-04-10
• Last updated: 2023-12-05

Locations

1 site across 1 country: France