Last reviewed · How we verify
NCT05611099
Robustness and Usability of the Dreem 3 System for at Home Sleep Monitoring in an Insomnia Population.
NA trial testing Dreem 3 System vs WatchPAT One in Insomnia, Secondary in 15 participants. Completed in 5 November 2022.
31 October 2022
Quick facts
| Lead sponsor | Dreem |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 15 |
| Start date | 15 August 2022 |
| Primary completion | 31 October 2022 |
| Estimated completion | 5 November 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dreem 3 System vs WatchPAT One
- Usability Questionnaire
Conditions studied
- Insomnia, Secondary — all drugs for Insomnia, Secondary →
- Sleep Disturbance — all drugs for Sleep Disturbance →
- Sleep — all drugs for Sleep →
- Sleep Initiation and Maintenance Disorders — all drugs for Sleep Initiation and Maintenance Disorders →
Sponsor
Dreem
Who can join
Adults 22 to 70, any sex, with Insomnia, Secondary or Sleep Disturbance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
There is an unmet medical need for monitoring sleep for multiple nights in a patient's home, without the inconvenience of traveling and staying overnight in a medical center, and without the need for a technician to set up a polysomnography (PSG) device at the patient's home. Several disorders, and particularly sleep disorders, are associated with insomnia symptoms, and longitudinal sleep assessment may support a better understanding and management of these patients, who currently seldom access sleep lab PSG. On one hand, this study aims at demonstrating whether the final device's user interface supports safe and effective use when being used at home over multiple nights. On the other, the study aims at confirming that stable and consistent data are measured in the device's actual use, for the records to be clinically usable in daily practice.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Usability and stability of longitudinal at-home sleep evaluation using the Waveband electroencephalogram headband in an insomnia population.
Savietto SF, Guillot A, Pathmanathan J, Harris M, et al · · 2026 · PMID 41710032 · DOI 10.1093/sleepadvances/zpag001
Verify or expand the search:
- PubMed search for NCT05611099
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Dreem trials
Trials by the same sponsor.
- NCT05438017 — Performance Evaluation of the Dreem 3 System for Sleep Assessment in Patients With Insomnia · NA · completed
- NCT03725943 — Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults · NA · completed
- NCT03657329 — Comparison of Dreem to Clinical PSG for Sleep Monitoring in Apnea Patients · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05611099 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dreem
- Last refreshed: 28 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05611099.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing