Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant

Overview

Journal Pharmaceut Med

Date 2023 Jun 7

PMID 37286927

Authors

Andrea Phillips-Beyer

Ariane K Kawata

Leah Kleinman

Dalma Seboek Kinter

Affiliations

Soon will be listed here.

Abstract

Background: The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a new validated 14-item patient-reported outcome (PRO) instrument for evaluating daytime functioning in people with insomnia. It comprises three domains: Alert/Cognition, Mood, and Sleepiness.

Objective: The aim of this analysis was to estimate the minimum within-patient change for IDSIQ scores that an adult patient with insomnia would consider meaningful.

Methods: Data were from a randomized, double-blind, placebo-controlled, phase III clinical trial of daridorexant in adults with insomnia. Subjects completed the IDSIQ daily in the evening, with a recall period of 'today', throughout the 3-month double-blind treatment period. Scores were calculated as a weekly average. Each IDSIQ item was scored on an 11-point numeric rating scale ranging from 0 (not at all/none at all) to 10 (very/a lot), with a higher score indicating a greater severity or impact. PRO measures with correlation coefficients ≥0.30 were included in a subsequent anchor-based analysis. For the IDSIQ total score and each IDSIQ domain, meaningful within-patient change was estimated as the minimum score change patients would consider meaningful in an anchor-based analysis using data from PRO instruments capturing daytime and night-time insomnia symptoms (the Insomnia Severity Index [four items, each scored 0-4, with a higher score indicating greater symptom severity; assessed at screening, baseline, month 1 and month 3], Patient Global Assessment of Disease Severity [6-point scale from 'none' to 'very severe'; assessed weekly], Patient Global Impression of Severity [4-point scale from 'none' to 'severe'; assessed weekly], and Patient Global Impression of Change [7-point scale from 'very much better' to 'very much worse'; assessed weekly for night-time and daytime symptoms separately]). A supplemental distribution-based analysis was also conducted to support the anchor-based analysis.

Results: The analysis included 930 subjects aged 18-88 years. Spearman correlation coefficients for the relationships between score changes/ratings for anchors and the IDSIQ (0.36-0.44 at month 1, 0.45-0.57 at month 3) were all above the prespecified threshold of 0.30. Mean IDSIQ score changes at months 1 and 3 based on the different anchors supported meaningful within-patient change estimates starting at 17 points for the IDSIQ total score, 9 points for the Alert/Cognition domain, and 4 points for the Mood and Sleepiness domains.

Conclusion: This analysis demonstrates the meaningful within-patient change for the IDSIQ total score and domain scores, that the instrument is sensitive to changes in the patient experience of insomnia, and that it can be used in clinical trials to evaluate changes in daytime functioning.

Clinical Trials Registration: NCT03545191 (4 June 2018).

Citing Articles

Content Validity Assessment of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Among Adults with Insomnia and Nocturia.

Kimel M, Kleinman L, Marco T, Olivieri A, Schulz A, Kirk K Patient. 2025; .

PMID: 40014275 DOI: 10.1007/s40271-025-00733-x.

References

Sheehan D, Lecrubier Y, Sheehan K, Amorim P, Janavs J, Weiller E . The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1999; 59 Suppl 20:22-33;quiz 34-57. View

Kyle S, Espie C, Morgan K . "...Not just a minor thing, it is something major, which stops you from functioning daily": quality of life and daytime functioning in insomnia. Behav Sleep Med. 2010; 8(3):123-40. DOI: 10.1080/15402002.2010.487450. View

Bell C, McLeod L, Nelson L, Fehnel S, Zografos L, Bowers B . Development and psychometric evaluation of a new patient-reported outcome instrument measuring the functional impact of insomnia. Qual Life Res. 2011; 20(9):1457-68. DOI: 10.1007/s11136-011-9885-8. View

Rejas J, Pardo A, Ruiz M . Standard error of measurement as a valid alternative to minimally important difference for evaluating the magnitude of changes in patient-reported outcomes measures. J Clin Epidemiol. 2008; 61(4):350-6. DOI: 10.1016/j.jclinepi.2007.05.011. View

Yang M, Morin C, Schaefer K, Wallenstein G . Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference. Curr Med Res Opin. 2009; 25(10):2487-94. DOI: 10.1185/03007990903167415. View

Bickley K, Lovato N, Lack L . The Sleep Impact on Activity Diary (SIAD): A Novel Assessment of Daytime Functioning in Insomnia. Brain Sci. 2021; 11(2). PMC: 7916926. DOI: 10.3390/brainsci11020219. View

Guyatt G, Osoba D, Wu A, Wyrwich K, Norman G . Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002; 77(4):371-83. DOI: 10.4065/77.4.371. View

Carey T, Moul D, Pilkonis P, Germain A, Buysse D . Focusing on the experience of insomnia. Behav Sleep Med. 2005; 3(2):73-86. DOI: 10.1207/s15402010bsm0302_2. View

Szentkiralyi A, Madarasz C, Novak M . Sleep disorders: impact on daytime functioning and quality of life. Expert Rev Pharmacoecon Outcomes Res. 2009; 9(1):49-64. DOI: 10.1586/14737167.9.1.49. View

10.

Billings M, Rosen C, Auckley D, Benca R, Foldvary-Schaefer N, Iber C . Psychometric performance and responsiveness of the functional outcomes of sleep questionnaire and sleep apnea quality of life instrument in a randomized trial: the HomePAP study. Sleep. 2014; 37(12):2017-24. PMC: 4548522. DOI: 10.5665/sleep.4262. View

11.

Revicki D, Hays R, Cella D, Sloan J . Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008; 61(2):102-9. DOI: 10.1016/j.jclinepi.2007.03.012. View

12.

Hudgens S, Phillips-Beyer A, Newton L, Seboek Kinter D, Benes H . Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2020; 14(2):249-268. PMC: 7884372. DOI: 10.1007/s40271-020-00474-z. View

13.

Folstein M, Folstein S, McHugh P . "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975; 12(3):189-98. DOI: 10.1016/0022-3956(75)90026-6. View

14.

Omachi T . Measures of sleep in rheumatologic diseases: Epworth Sleepiness Scale (ESS), Functional Outcome of Sleep Questionnaire (FOSQ), Insomnia Severity Index (ISI), and Pittsburgh Sleep Quality Index (PSQI). Arthritis Care Res (Hoboken). 2012; 63 Suppl 11:S287-96. PMC: 3711174. DOI: 10.1002/acr.20544. View

15.

Scrima L, Emsellem H, Becker P, Ruoff C, Lankford A, Bream G . Identifying clinically important difference on the Epworth Sleepiness Scale: results from a narcolepsy clinical trial of JZP-110. Sleep Med. 2017; 38:108-112. DOI: 10.1016/j.sleep.2017.07.006. View

16.

Wyrwich K, Tierney W, Wolinsky F . Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol. 1999; 52(9):861-73. DOI: 10.1016/s0895-4356(99)00071-2. View

17.

Mignot E, Mayleben D, Fietze I, Leger D, Zammit G, Bassetti C . Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022; 21(2):125-139. DOI: 10.1016/S1474-4422(21)00436-1. View

18.

Kunz D, Dauvilliers Y, Benes H, Garcia-Borreguero D, Plazzi G, Seboek Kinter D . Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder. CNS Drugs. 2022; 37(1):93-106. PMC: 9829592. DOI: 10.1007/s40263-022-00980-8. View

19.

Leidy N, Wyrwich K . Bridging the gap: using triangulation methodology to estimate minimal clinically important differences (MCIDs). COPD. 2006; 2(1):157-65. DOI: 10.1081/copd-200050508. View

20.

Bastien C, Vallieres A, Morin C . Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001; 2(4):297-307. DOI: 10.1016/s1389-9457(00)00065-4. View