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NCT01485393
Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
NA trial testing Dexmedetomidine in Insomnia in 10 participants. Completed in 29 June 2018.
29 January 2018
Quick facts
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 10 |
| Start date | 1 January 2015 |
| Primary completion | 29 January 2018 |
| Estimated completion | 29 June 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dexmedetomidine (dexmedetomidine) — full drug profile →
- Zolpidem (zolpidem) — full drug profile →
Conditions studied
- Insomnia — all drugs for Insomnia →
Sponsor
Massachusetts General Hospital
Who can join
Adults 18 to 35, any sex, with Insomnia. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change in Sleep Quality
Time frame: Approximately 8 hours
Sleep quality will be assessed objectively through EEG measures (changes from baseline in length of non-REM sleep, length of REM sleep, and length of N3 sleep--all assessed in minutes) and subjectively, utilizing a post sleep questionnaire to assess the difference in quantity of sleep (minutes) from baseline. Sleep quality is directly related to these measures of sleep quantity.
Sponsor's own description
The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Dexmedetomidine promotes biomimetic non-rapid eye movement stage 3 sleep in humans: A pilot study.
Akeju O, Hobbs LE, Gao L, Burns SM, et al · · 2018 · cited 103× · PMID 29154132 · DOI 10.1016/j.clinph.2017.10.005
Verify or expand the search:
- PubMed search for NCT01485393
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dexmedetomidine
Trials testing the same drug.
- NCT06824077 — Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle · EARLY_PHASE1 · not yet recruiting
- NCT07398066 — DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial) · NA · not yet recruiting
- NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
- NCT07306702 — Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients · Phase 4 · withdrawn
- NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting
Other recruiting trials for Insomnia
Currently open trials in the same condition.
- NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
- NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain · NA · recruiting
- NCT07071324 — CF Wellness Program · NA · recruiting
- NCT07417813 — A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders · recruiting
- NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES) · NA · recruiting
Other Massachusetts General Hospital trials
Trials by the same sponsor.
- NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
- NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
- NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
- NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
- NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting
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 NCT01485393 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Massachusetts General Hospital
- Last refreshed: 7 October 2019
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/NCT01485393.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing