Trial abstract
DSIP-HIST-SLEEP — structured trial abstract
DSIP-HIST-SLEEP — DSIP in sleep: randomised crossover
§1Structured abstract
§1.1Objective
To evaluate DSIP in sleep initiation and maintenance disorders, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Randomised, double-blind, placebo-controlled, crossover
- Masking
- Double-blind with a washout between periods
- Phase
- Not applicable
- Randomised participants
- not recorded by the Institute
- Duration of the primary analysis period
- Not recorded
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Sleep architecture measured by polysomnography
§1.4Principal result
Historical crossover studies in small samples reported inconsistent effects on sleep architecture. No modern controlled trial has been identified.
§1.5Provenance of this abstract
Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.
| Field | Provenance | Note |
|---|---|---|
| Design, phase, duration, primary endpoint | Extracted | Reproduced from the published report or the registry record. |
| Randomised participants | Not held | Not recorded by the Institute. The field is left empty rather than estimated. |
| Principal result | Extracted | Reproduced as published, with the confidence interval where the Institute holds it. |
| Centres, countries and baseline characteristics | Reconstructed | Derived by the Institute from the design class and the randomised total. Presented in §2 as an illustrative operational profile and marked as such. These figures are not published characteristics of this trial. |
| Certainty assessment | Institute judgement | The Institute’s own domain-by-domain assessment, with reasoning recorded against each domain in §4. |
| Registry identifier | Not held | The Institute does not reproduce a registry identifier it has not verified and never constructs one. Documents are referenced by the Institute’s own identifier. |
Compound Evidence Institute · CEI-TR-0127 · https://compoundevidence.com/trials/dsip-hist-sleep/ · retrieved 30 July 2026