Trial abstract · §2
DSIP-HIST-SLEEP — design and population
Design, allocation, arms and the population enrolled.
§2Design and population
§2.1Design and allocation
- Design class
- Randomised, double-blind, placebo-controlled, crossover
- Masking
- Double-blind with a washout between periods
- Arms
- 2
- Allocation
- Randomised to treatment sequence, with a washout between periods
- Endpoint adjudication
- Not applicable to the primary endpoint of this design
- Data monitoring
- As specified in the protocol
§2.2Arms
Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.
| Arm | Allocated | Share | Description |
|---|---|---|---|
| DSIP | — | — | Intervention at the dose reached after titration |
| Placebo | — | — | Matched placebo, administered on the same schedule |
| The randomised total is not recorded by the Institute and arm-level figures are therefore not presented. | |||
§2.3Population
Indication. Sleep initiation and maintenance disorders
Difficulty initiating or maintaining sleep with daytime consequences, assessed by polysomnography, actigraphy or validated questionnaires.
Geographic footprint. Norway · Netherlands · Japan.
§2.4Eligibility as the Institute reads it
- Included. Difficulty initiating or maintaining sleep with daytime consequences, assessed by polysomnography, actigraphy or validated questionnaires.
- Excluded. Participants for whom the intervention is contraindicated, including not established — no marketing authorisation. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.
Compound Evidence Institute · CEI-TR-0127/2 · https://compoundevidence.com/trials/dsip-hist-sleep/design/ · retrieved 30 July 2026