gms | German Medical Science

Hintergrund: The Sleep Diary Questionnaire (SDQ) is a new content-valid 17-item sleep diary adapted from the Consensus Sleep Diary, assessing key sleep parameters including total time asleep the previous night or subjective total sleep time (sTST).

Fragestellung: People with insomnia value increasing sTST as a key treatment outcome. We estimated meaningful within-patient change for sTST in adults with insomnia.

Methoden: Data from a phase-2 open-label trial (NCT03056053) and blinded data from a phase-3 randomized controlled trial (NCT03545191) were used. Subjects completed the SDQ daily. Changes in weekly average sTST were calculated using anchor-based analyses including patient- and clinician-reported outcome measures whose correlations with change in weekly average sTST were at least moderate (Spearman correlation coefficient ≥|0.3|). Outcome measures were Insomnia Severity Index, Patient Global Assessment of Disease Severity, Patient Global Impression of Severity, Patient Global Impression of Change, Clinician Global Impression of Severity, and Clinician Global Impression of Change. Distribution-based analyses calculated standard error of measurement (SEM) as supportive evidence. Change estimates from anchor- and distribution-based analyses were “triangulated” to identify a value where they converged.

Ergebnisse: In the phase 2 trial (N=114), mean sTST increases from baseline in subjects with meaningful improvements on the anchors were 60.1–83.2 min at day 8 and 55.5–93.5 min at day 15. SEM was 51.1 min at day 8 and 55.5 min at day 15. In the phase 3 trial (N=930, pooled across treatment arms), mean sTST increases were 36.5–76.2 min at month 1 and 47.3–87.7 min at month 3. SEM was 43.2 min at month 1 and 53.3 min at month 3. Triangulation of results supported a meaningful change threshold of 55 min.

Diskussion: Our findings support the importance of using sTST to assess insomnia from the patient’s perspective.

Take Home Message für die Praxis: The data provide useful information that an increase in sleep time of almost 1 hour is meaningful to patients.