Sedative Drug ConsumptionPhase 2/3MUSICNCT00880035
Efficacy of Music on Reduction of Sedative Drugs in Mechanically Ventilated Intensive Care Unit Patients
A Phase 2/3 study testing MP3 music program listening in people with Sedative Drug Consumption and Mechanically Ventilated ICU Patients, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Impact on sedative drug consumption. 2. Alteration of stress neuropeptide blood concentrations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedative Drug Consumption, Mechanically Ventilated ICU Patients
- What is being tested?
- MP3 music program listening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to Dec 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- hearing impairment
- pregnancy
- needs of vasopressin
- needs of curarisation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: M.U.S.I.C (MUSicotherapy in the Intensive Care) Interventional, Pilot, Cross-Over, in Mechanically-Ventilated Patients on ICU Ward
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:
- Impact on sedative drug consumption.
- Alteration of stress neuropeptide blood concentrations.
Population: mechanically-ventilated ICU patients
The investigators hypothesize the music will decrease the need of sedative drugs and reduce the concentration of neuropeptides in circulation.
Read the detailed description
The study will imply patients mechanically ventilated for more than 3 days, that require sedation with benzodiazepine and narcotics.
There will be two groups both of exposed to music and placebo (headphones without music). The study will be simple blind.
Sedation scale will be followed regularly. Vitals signs and adjustment of sedation will be recorded by the nurse on the ward. Blood test will be taken before and after placement of headphones in the morning. We will measure IL-6, cortisol, copeptin, prolactin, CRP.
We will analyse the total reduction dose of sedation and analgesia on a daily basis. We will consider a fall of 20% of medication to be significative.
- Being tested
- MP3 music program listening
- Keywords
- sedative drug, stress, music, mechanical ventilation, IL-6, cortisol, prolactin, CRP, copeptin
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A: day 1 = music, day 2 = washout, day 3 = headphone without music Receives: Device: MP3 music program listening |
| Group B | Experimental | Group B: day 1 = headphone without music, day 2 = washout, day 3 = music Receives: Device: MP3 music program listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
sedative drug consumption in mechanically ventilated ICU patients
Measured: 3 days
Secondary outcomes (1)
stress neuropeptide blood content evolution with MUSIC listening
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionJul 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedative Drug ConsumptionStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche Clinique CHUS
- Investigators
- Olivier Lesur, MD, Principal investigator, CHUS and Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880035
- Sponsor's protocol ID
- 08-105-R2
- Other IDs
- CRC-PAFI-09
- Acronym
- MUSIC
- Status last verified
- Apr 2009
- First submitted
- 10 Apr 2009
- Last updated
- 22 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- M.U.S.I.C (MUSicotherapy in the Intensive Care) Interventional, Pilot, Cross-Over, in Mechanically-Ventilated Patients on ICU Ward
- ClinicalTrials.gov ID
- NCT00880035
- Acronym / sponsor ID
- MUSIC / 08-105-R2
- Keywords
- sedative drug, stress, music, mechanical ventilation, IL-6, cortisol, prolactin, CRP
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Centre de Recherche Clinique CHUS
- Study start
- Dec 2008
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 13 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Impact on sedative drug consumption.
- Alteration of stress neuropeptide blood concentrations.
Population: mechanically-ventilated ICU patients
The investigators hypothesize the music will decrease the need of sedative drugs and reduce the concentration of neuropeptides in circulation.
Detailed description
The study will imply patients mechanically ventilated for more than 3 days, that require sedation with benzodiazepine and narcotics.
There will be two groups both of exposed to music and placebo (headphones without music). The study will be simple blind.
Sedation scale will be followed regularly. Vitals signs and adjustment of sedation will be recorded by the nurse on the ward. Blood test will be taken before and after placement of headphones in the morning. We will measure IL-6, cortisol, copeptin, prolactin, CRP.
We will analyse the total reduction dose of sedation and analgesia on a daily basis. We will consider a fall of 20% of medication to be significative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: MP3 music program listeningGroup A: day 1 = music, day 2 = washout, day 3 = headphone without music |
| Group B | Experimental | Device: MP3 music program listeningGroup B: day 1 = headphone without music, day 2 = washout, day 3 = music |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- hearing impairment
- pregnancy
- needs of vasopressin
- needs of curarisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MP3 music program listening3 days with two 1 hour periods of headset music listening (1 day on, 1 day wash-out, 1 day off) | Device | Group A, Group B |
Primary outcome
sedative drug consumption in mechanically ventilated ICU patients
Time frame: 3 days
1 secondary outcome
stress neuropeptide blood content evolution with MUSIC listening
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Lesur, MD principal investigator
CHUS and Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MP3 music program listening in people with Sedative Drug Consumption and Mechanically Ventilated ICU Patients, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Lesur, MD ((819)346-1110, olivier.lesur@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sedative drug consumption in mechanically ventilated ICU patients (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2009.