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

• Sponsor: University of Bordeaux (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05805527
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 5

Study Details

Study Description

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 (include the name of the instrument to evaluate acceptability)

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Disorder	Diagnostic Test: mobile health application named KANOPEE

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Evaluating the Validity and Acceptability of a Fully-automated Interview to Diagnose Insomnia Disorder: a Pilot Study
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Outcome Measures

Primary Outcome Measures

1. Concurrent validity (sensitivity and specificity) [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 Outcome Measures

1. Acceptability of the fully-automated interview [May-July 2023]

   This outcome will be assessed with a validated questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Bordeaux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Auriacombe M, Fournet L, Dupuy L, Micoulaud-Franchi JA, de Sevin E, Moriceau S, Baillet E, Alexandre JM, Serre F, Philip P. Effectiveness and Acceptance of a Smartphone-Based Virtual Agent Screening for Alcohol and Tobacco Problems and Associated Risk Factors During COVID-19 Pandemic in the General Population. Front Psychiatry. 2021 Jul 16;12:693687. doi: 10.3389/fpsyt.2021.693687. eCollection 2021.
• Dupuy L, Morin CM, de Sevin E, Taillard J, Salles N, Bioulac S, Auriacombe M, Micoulaud-Franchi JA, Philip P. Smartphone-based virtual agents and insomnia management: A proof-of-concept study for new methods of autonomous screening and management of insomnia symptoms in the general population. J Sleep Res. 2022 Apr;31(2):e13489. doi: 10.1111/jsr.13489. Epub 2021 Sep 18.
• Philip P, Dupuy L, Morin CM, de Sevin E, Bioulac S, Taillard J, Serre F, Auriacombe M, Micoulaud-Franchi JA. Smartphone-Based Virtual Agents to Help Individuals With Sleep Concerns During COVID-19 Confinement: Feasibility Study. J Med Internet Res. 2020 Dec 18;22(12):e24268. doi: 10.2196/24268.
• Philip P, Dupuy L, Sagaspe P, de Sevin E, Auriacombe M, Taillard J, Micoulaud-Franchi JA, Morin CM. Efficacy of a Smartphone-Based Virtual Companion to Treat Insomniac Complaints in the General Population: Sleep Diary Monitoring Versus an Internet Autonomous Intervention. J Clin Med. 2022 Jul 28;11(15):4387. doi: 10.3390/jcm11154387.

• Responsible Party: Pierre Philip, Professor, University of Bordeaux
• ClinicalTrials.gov Identifier: NCT05805527
• Other Study ID Numbers: 0000
• First Posted: Apr 10, 2023
• Last Update Posted: Apr 10, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pierre Philip, Professor, University of Bordeaux: Insomnia Disorder; Mobile health; Diagnosis
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Disease

Study Results

No Results Posted as of Apr 10, 2023