NCT00286936

Brief Summary

To examine the influence of regular hypnotic therapy on the incidence of delirium after hip fracture surgery

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

August 30, 2011

Status Verified

September 1, 2006

First QC Date

February 3, 2006

Last Update Submit

August 29, 2011

Conditions

Hip FractureDelirium

Keywords

Hip fracturedeliriumsleep disturbancehypnotic

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of postoperative delirium

Secondary Outcomes (6)

  • Sleep quality

  • mobilization

  • loss of functional ability

  • length of stay

  • sedation

  • +1 more secondary outcomes

Interventions

ZolpidemDRUG

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Primary hip fracture, no substance abuse, no regular opioid, corticosteroid or benzodiazepine therapy, hepatic insufficiency, myastenia gravis, allergies to drug components

You may not qualify if:

  • Severe respiratory insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Hip FracturesDeliriumParasomnias

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersSleep Wake Disorders

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nicolai B Foss, MD

    Hvidovre University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2006

First Posted

February 6, 2006

Study Start

February 1, 2004

Study Completion

January 1, 2007

Last Updated

August 30, 2011

Record last verified: 2006-09

Locations

DK(1)