MetabolismNCT03231163
Physiological and Perceptual Effects of Music on Resting Metabolic Rate (RMR)
A study testing No Music, Relaxing Classical Music and Self-Selected Relaxing Music in people with Metabolism, run by Old Dominion University at 1 site in United States.
Trial summary
The objective of the study is to determine whether music has any effect on resting metabolic rate (RMR), which is the amount of energy expended at rest. There is currently conflicting research on how music affects RMR. One problem with RMR testing is that participants often fall asleep during the test. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism
- What is being tested?
- No Music, Relaxing Classical Music and Self-Selected Relaxing Music
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2017to 3 Oct 2017
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Any metabolic disorder, or significant cardiopulmonary disease
- Taking medications that are known to affect RMR
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Performance Laboratory
Norfolk, Virginia, 23529
About this study
The objective of the study is to determine whether music has any effect on resting metabolic rate (RMR), which is the amount of energy expended at rest. There is currently conflicting research on how music affects RMR. One problem with RMR testing is that participants often fall asleep during the test. There can be a 5-10% difference in the metabolic rate between rest and sleep. If no change in RMR is observed, playing music during an RMR test could be a potential strategy to prevent participants from falling asleep. Participants will undergo RMR measurements while listening to no music, relaxing classical music, and self-selected classical music.
- Conditions
- Metabolism
- Being tested
- No Music, Relaxing Classical Music, Self-Selected Relaxing Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No MusicOther
Participants lie supine on a table while no music is played.
Relaxing Classical MusicOther
Participants lie supine on a table while classical music is played.
Self-Selected Relaxing MusicOther
Participants lie supine on a table while self-selected relaxing music is played.
| Study group | Role | What they receive |
|---|---|---|
| No Music | Placebo comparator | Not described Receives: Other: No Music |
| Relaxing Classical Music | Experimental | Not described Receives: Other: Relaxing Classical Music |
| Self-Selected Relaxing Music | Experimental | Not described Receives: Other: Self-Selected Relaxing Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Resting Metabolic Rate
RMR will be measured via indirect calorimetry (Parvomedics TrueOne system)
Measured: Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. RMR will be measured continuously over each 15 min trial.
Secondary outcomes (3)
Heart rate
Heart rate will be measured with a Polar chest strap monitor
Measured: Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. Heart rate will be measured continuously over each 15 min trial.
Excited/bored scale
Participants rate on a 0-9 Likert scale how bored or excited they are.
Measured: Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. Levels of boredom/excitement will be measured at the end of each 15 min trial.
Sleepiness scale
Participants rate on a 0-9 Likert scale how sleepy they are.
Measured: Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. Levels of sleepiness will be measured at the end of each 15 min trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start5 Jul 2017
- Primary completion3 Oct 2017
- Study completion3 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolismStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Old Dominion University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Wilson, PhD, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231163
- Sponsor's protocol ID
- 1082672-3
- Status last verified
- Dec 2017
- First submitted
- 23 Jul 2017
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Perceptual Effects of Music on Resting Metabolic Rate (RMR)
- ClinicalTrials.gov ID
- NCT03231163
- Acronym / sponsor ID
- 1082672-3
- Conditions
- Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 27 Jul 2017 (actual)
- 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.
The objective of the study is to determine whether music has any effect on resting metabolic rate (RMR), which is the amount of energy expended at rest. There is currently conflicting research on how music affects RMR. One problem with RMR testing is that participants often fall asleep during the test. There can be a 5-10% difference in the metabolic rate between rest and sleep. If no change in RMR is observed, playing music during an RMR test could be a potential strategy to prevent participants from falling asleep. Participants will undergo RMR measurements while listening to no music, relaxing classical music, and self-selected classical music.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Music | Placebo comparator | Other: No Music |
| Relaxing Classical Music | Experimental | Other: Relaxing Classical Music |
| Self-Selected Relaxing Music | Experimental | Other: Self-Selected Relaxing Music |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Any metabolic disorder, or significant cardiopulmonary disease
- Taking medications that are known to affect RMR
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 |
|---|---|---|
| No MusicParticipants lie supine on a table while no music is played. | Other | No Music |
| Relaxing Classical MusicParticipants lie supine on a table while classical music is played. | Other | Relaxing Classical Music |
| Self-Selected Relaxing MusicParticipants lie supine on a table while self-selected relaxing music is played. | Other | Self-Selected Relaxing Music |
Primary outcome
Daily Resting Metabolic Rate
Time frame: Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. RMR will be measured continuously over each 15 min trial.
RMR will be measured via indirect calorimetry (Parvomedics TrueOne system)
3 secondary outcomes
Heart rate
Time frame: Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. Heart rate will be measured continuously over each 15 min trial.
Excited/bored scale
Time frame: Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. Levels of boredom/excitement will be measured at the end of each 15 min trial.
Sleepiness scale
Time frame: Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. Levels of sleepiness will be measured at the end of each 15 min trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Music, Relaxing Classical Music and Self-Selected Relaxing Music in people with Metabolism, run by Old Dominion University at 1 site in United States.
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 0 inclusion and 2 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: finished, as of the sponsor's last update on 20 Dec 2017. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Resting Metabolic Rate (time frame: Participants will be randomized to three consecutive 15-minute trials involving listening to no music, classical music, or self-selected relaxing music. RMR will be measured continuously over each 15 min trial.). 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 20 Dec 2017.