NCT00880035

Brief Summary

Major objective: a three-days interventional cross-over trial \[one day music on, one day wash-out, one day music off\]\[two periods of listening/day\], to evaluate:

  1. 1.Impact on sedative drug consumption.
  2. 2.Alteration of stress neuropeptide blood concentrations.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 22, 2009

Status Verified

April 1, 2009

Enrollment Period

1.6 years

First QC Date

April 10, 2009

Last Update Submit

April 20, 2009

Conditions

Sedative Drug ConsumptionMechanically Ventilated ICU Patients

Keywords

sedative drugstressmusicmechanical ventilationIL-6cortisolprolactinCRPcopeptin

Outcome Measures

Primary Outcomes (1)

  • sedative drug consumption in mechanically ventilated ICU patients

    3 days

Secondary Outcomes (1)

  • stress neuropeptide blood content evolution with MUSIC listening

    3 days

Study Arms (2)

Group A

EXPERIMENTAL

Group A: day 1 = music, day 2 = washout, day 3 = headphone without music

Device: MP3 music program listening

Group B

EXPERIMENTAL

Group B: day 1 = headphone without music, day 2 = washout, day 3 = music

Device: MP3 music program listening

Interventions

MP3 music program listeningDEVICE

3 days with two 1 hour periods of headset music listening (1 day on, 1 day wash-out, 1 day off)

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults older than 18 years old
  • expected time of mechanical ventilation of more than 72 hours
  • sedation needs for a scale of Sedation-Agitation Scale (SAS) more than 1

You may not qualify if:

  • hearing impairment
  • pregnancy
  • needs of vasopressin
  • needs of curarisation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Olivier Lesur, MD

    CHUS and Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Lesur, MD

CONTACT

(819)346-1110[email protected]

Catherine St-Pierre, MD

CONTACT

(819)346-1110[email protected]

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 13, 2009

Study Start

December 1, 2008

Primary Completion

July 1, 2010

Study Completion

December 1, 2010

Last Updated

April 22, 2009

Record last verified: 2009-04

Locations

CA(1)