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The Sleep Diary Questionnaire (SDQ), a modified version of the Consensus Sleep Diary, serves as a 17-item sleep diary utilized in insomnia trials to determine subjective total sleep time (sTST) and other sleep parameters. Determining the clinical significance of improvement in sTST for those dealing with insomnia disorder remains uncertain. Hence, this study sought to establish a meaningful within-patient change for sTST utilizing clinical trial data.
Improving subjective total sleep time by approximately 55 minutes serves as a meaningful marker of progress in insomnia management.
The Sleep Diary Questionnaire (SDQ), a modified version of the Consensus Sleep Diary, serves as a 17-item sleep diary utilized in insomnia trials to determine subjective total sleep time (sTST) and other sleep parameters. Determining the clinical significance of improvement in sTST for those dealing with insomnia disorder remains uncertain. Hence, this study sought to establish a meaningful within-patient change for sTST utilizing clinical trial data.
From the open-label trial of Zolpidem and combined data from a phase III placebo-controlled trial of Daridorexant, data extraction was done. The enrolled participants (adults having moderate to severe insomnia) accomplished the SDQ daily.
A meaningful alteration in sTST was determined through an anchor-based analysis, employing outcome measures correlated with alterations in weekly average sTST (Spearman correlation coefficient ≥ 0.30), including the Insomnia Severity Index (ISI), patient global assessments, impressions of intensity and alteration in daytime and nighttime symptoms (Patient Global Assessment of Disease Severity [PGA-S], Patient Global Impression of Severity [PGI-S], Patient Global Impression of Change [PGI-C]), and clinician global impressions of intensity and alteration in patients' daytime symptoms (Clinician Global Impression of Severity [CGI-S], Clinician Global Impression of Change [CGI-C]). For identifying a consistent value, estimates of meaningful within-patient change were converged.
In the open-label trial (N = 114), individuals showing a 1-point or 1-step betterment on the anchors experienced a mean rise in sTST ranging from 60.1 to 83.2 minutes by day 8 and 55.5 to 68.2 minutes by day 15. Those having a 2-point or 2-step betterment experienced a mean rise in sTST of 79.6 to 81.4 minutes on day 8 and 80.1 to 93.5 minutes on day 15.
In the phase III trial (N = 930), subjects having a 1-point or 1-step betterment illustrated a weekly average rise in sTST ranging from 39.3 to 46.7 minutes in the first month and 47.3 to 58.3 minutes in the third month. For those having a 2-point or 2-step betterment, the mean rise in sTST was 60.7 to 76.2 minutes at month 1 and 70.1 to 87.7 minutes at month 3. The convergence of these values favored a considerable within-patient change threshold commencing at 55 minutes.
Enhancing sTST stands as a fundamental treatment outcome for individuals with insomnia. An escalation in sleep time of about 55 minutes holds clinical significance for patients.
Pharmaceutical Medicine
Meaningful Within-Patient Change in Subjective Total Sleep Time in Patients with Insomnia Disorder: An Analysis of the Sleep Diary Questionnaire Using Data from Open-Label and Phase III Clinical Trials
Andrea Phillips-Beyer et al.
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