Clinical trial NCT05805527: Evaluating the Validity and Acceptability of a Fully-automated Interview to Diagnose Insomnia Disorder: a Pilot Study
Official title: Evaluating the Validity and Acceptability of a Fully-automated Interview to Diagnose Insomnia Disorder: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insomnia Disorder
Keywords: Insomnia Disorder
Mobile health
Diagnosis
Lead sponsor: University of Bordeaux
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteer patients attending the sleep clinic at the Bordeaux University Hospital

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Concurrent validity (sensitivity and specificity)
timeFrame: May-July 2023
Secondary outcomes:
measure: Acceptability of the fully-automated interview
timeFrame: May-July 2023
measure: Perceptions of the virtual agent
timeFrame: May-July 2023
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital of Bordeaux
Study officials:
affiliation: Universite de Bordeaux, France - Universidad de Murcia, Spain
name: Maria M Sanchez Ortuno, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.