NCT03231163

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 5, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2017

Completed
Last Updated

December 20, 2017

Status Verified

December 1, 2017

Enrollment Period

3 months

First QC Date

July 23, 2017

Last Update Submit

December 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Daily Resting Metabolic Rate

    RMR will be measured via indirect calorimetry (Parvomedics TrueOne system)

    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

    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 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 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.

Study Arms (3)

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

Interventions

Participants lie supine on a table while no music is played.

No Music

Participants lie supine on a table while classical music is played.

Relaxing Classical Music

Participants lie supine on a table while self-selected relaxing music is played.

Self-Selected Relaxing Music

Eligibility Criteria

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

You may not qualify if:

  • Any metabolic disorder, or significant cardiopulmonary disease
  • Taking medications that are known to affect RMR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Performance Laboratory

Norfolk, Virginia, 23529, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Exercise Science

Study Record Dates

First Submitted

July 23, 2017

First Posted

July 27, 2017

Study Start

July 5, 2017

Primary Completion

October 3, 2017

Study Completion

October 3, 2017

Last Updated

December 20, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations