Insomnia DisorderNCT05805527
Evaluating the Validity and Acceptability of a Fully-automated Interview to Diagnose Insomnia Disorder: a Pilot Study
An observational study of Insomnia Disorder, run by University of Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- mobile health application named KANOPEE
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2023to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Volunteer patients attending the sleep clinic at the Bordeaux University Hospital
Who may be able to join
- Aged 18 years or older
- Being able to communicate and read in French
- Previous use a mobile phone
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this 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:
Read more
- 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
- 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
- Being tested
- mobile health application named KANOPEE
- Keywords
- Insomnia Disorder, Mobile health, Diagnosis
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile health application named KANOPEEDiagnostic test
Volunteers will undergo two clinical interviews, an in person clinician-led interview and a fully-automated interview administered via mobile phone
What is being measured
The primary outcome is the main question the study is designed to answer.
Concurrent validity (sensitivity and specificity)
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
Measured: May-July 2023
Secondary outcomes (2)
Acceptability of the fully-automated interview
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.
Measured: May-July 2023
Perceptions of the virtual agent
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.
Measured: May-July 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 May 2023
- Primary completion31 Jul 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Philip, University of Bordeaux
- Investigators
- Maria M Sanchez Ortuno, PhD, Study director, Universite de Bordeaux, France - Universidad de Murcia, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805527
- Sponsor's protocol ID
- 0000
- Status last verified
- Nov 2023
- First submitted
- 27 Mar 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33264099Auriacombe 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.
PubMed 34335332Dupuy 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.
PubMed 34535942Philip 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.
PubMed 35956005
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Validity and Acceptability of a Fully-automated Interview to Diagnose Insomnia Disorder: a Pilot Study
- ClinicalTrials.gov ID
- NCT05805527
- Acronym / sponsor ID
- 0000
- Conditions
- Insomnia Disorder
- Keywords
- Insomnia Disorder, Mobile health, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of BordeauxUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer patients attending the sleep clinic at the Bordeaux University Hospital
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Being able to communicate and read in French
- Previous use a mobile phone
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile health application named KANOPEEVolunteers will undergo two clinical interviews, an in person clinician-led interview and a fully-automated interview administered via mobile phone | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
Acceptability of the fully-automated interview
Time frame: May-July 2023
Perceptions of the virtual agent
Time frame: May-July 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 33264099Philip 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.
- Background: PubMed 34335332Auriacombe 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.
- Background: PubMed 34535942Dupuy 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.
- Background: PubMed 35956005Philip 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria M Sanchez Ortuno, PhD study director
Universite de Bordeaux, France - Universidad de Murcia, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia Disorder, run by University of Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concurrent validity (sensitivity and specificity) (time frame: May-July 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05805527, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.