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DARIdorexant efficacy on the COGnitive performance in patients with chronic insomnia disorder. DARI-COG Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517768-52-00
Enrollment
25
Registered
2025-03-04
Start date
2025-07-11
Completion date
Unknown
Last updated
2025-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insonnia cronica

Brief summary

1. Change in insomnia severity index (ISI) total score at 3- and 6-month follow-up visits; 2. Change in subjective total sleep time (sTST) measured by sleep diary in the 7 days before the visit planned at 3- and 6-month follow-up;

Detailed description

Change in cogn perf (attention and memory) measured by neuropsychological tests at the 3and 6monthFUvisits;Change in PSQI total and sub-items scores at 3and 6monthFUvisits;Change in ESS scores at 3and 6monthFUvisits;Change in MEQ scores at 3and 6monthFUvisits;Change in Beck Depression Inventory-II total score at 3and 6monthFUvisits;Change in the mental and physical component of the SF-12 at 3and 6monthFUvisits.

Interventions

Sponsors

Universita' Degli Studi Di Roma Tor Vergata
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
1. Change in insomnia severity index (ISI) total score at 3- and 6-month follow-up visits; 2. Change in subjective total sleep time (sTST) measured by sleep diary in the 7 days before the visit planned at 3- and 6-month follow-up;

Secondary

MeasureTime frame
Change in cogn perf (attention and memory) measured by neuropsychological tests at the 3and 6monthFUvisits;Change in PSQI total and sub-items scores at 3and 6monthFUvisits;Change in ESS scores at 3and 6monthFUvisits;Change in MEQ scores at 3and 6monthFUvisits;Change in Beck Depression Inventory-II total score at 3and 6monthFUvisits;Change in the mental and physical component of the SF-12 at 3and 6monthFUvisits.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026