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Efficacy of Wholetones® 2Sleep Music on Health and Sleep Behaviors of Healthy Adults With Insomnia Symptoms

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ClinicalTrials.gov Identifier: NCT03928301
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Heather Hausenblaus, Jacksonville University

Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE January 15, 2019
Actual Primary Completion Date March 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Change In Pittsburgh Sleep Quality Index Scores from Baseline to those at Days 17 & 31 [ Time Frame: Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition) ]
    Self report data used to determine how well participants perceived their sleep quality at Day 0 (baseline), Day 17 (after first music condition Wholetones or classical), and Day 31 (after alternate music condition). This survey consists of 9 total items (some items have sub questions i.e. item 4 which has parts A and B). Scores are calculated as per survey instructions. Any scores of 5 or above indicate poor perceived sleep quality.
  • Change In Profile of Mood States (POMS) Scores from Baseline to Days 17 & 31 [ Time Frame: Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition) ]
    Self report data used to determine the perceived mood of participants at Day 0 (baseline), Day 17 (after first music condition Wholetones or classical), and Day 31 (after alternate music condition). This questionnaire has 65 total items and responses are calculated by scoring question responses on a Likert scale fro 0-4, where 0= not at all and 4= extremely. Total numeric scores are determined for the 6 sub scales represented in the survey (i.e. depression, anger, vigor, confusion, tension, and anger) based on which category the item represents. These sub scale scores are then tallied to determine and overall mood score, where higher scores indicate higher levels of depression, anger, tension, confusion, and fatigue. Being that vigor is a positive indicator for mood, these items are reverse scored before being tallied.
  • Change in State Trait Anxiety Inventory Scores from Baseline to Days 17 & 31 [ Time Frame: Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition) ]
    Self report data used to determine the perceived anxiety levels of participants at Day 0 (baseline), Day 17 (after first music condition Wholetones or classical), and Day 31 (after alternate music condition). This survey has 20 total items, and responses are scored on a Likert scale of 1-4 where 1=almost never and 4=almost always. Any items that are positive are reverse scored before totaling all 20 items. Higher scores indicate higher levels of perceived anxiety.
  • Change In Perceived Stress Scale Scores at Baseline from Days 17 & 31 [ Time Frame: Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition) ]
    Self report data used to determine the perceived stress levels of participants at Day 0 (baseline), Day 17 (after first music condition Wholetones or classical), and Day 31 (after alternate music condition). This survey has 10 total items, and responses are scored on a Likert scale from 0-4 where 0=Never and 4=Very often. Any items that are positive are reverse scored before totaling all 10 items. Higher scores indicate higher levels of perceived stress.
  • Change In Flinder's Fatigue Scale Scores from Baseline to Days 17 & 31 [ Time Frame: Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition) ]
    Self report data used to determine the perceived fatigue levels of participants at Day 0 (baseline), Day 17 (after first music condition Wholetones or classical), and Day 31 (after alternate music condition). This survey has 7 total items, and 6 out of the 7 items are scored on a 5-point Likert scale of 0 (Not at all) to 4 (Extremely). The 7th item asks participants during which times of day they typically experience the most fatigue (out of 7 possible options), each time that indicate is counted as a "1" and all times selected are added to determine a score for that item. All 7 items are then tallied to determine a final score, where higher scores indicate higher levels of perceived fatigue.
  • Change In Productivity Scores from Baseline to Days 17 & 31 [ Time Frame: Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition) ]
    Self report data used to determine the perceived productivity levels of participants at Day 0 (baseline), Day 17 (after first music condition Wholetones or classical), and Day 31 (after alternate music condition). This was determined using 1 item from a Life Satisfaction survey. It was scored using a Likert scale where 1 represented "Very Unproductive" and 4 "Very Productivity". Higher scores indicate higher levels of perceived productivity.
  • EMFIT Sleep Tracker data [ Time Frame: This data was collected for the 1-month duration of the study (7 days of baseline, 20 days of intervention, 4 days of washout). ]
    EMFIT sleep tracker reports served as the objective sleep data for the study. Sleep data was collected during the night while participants slept in their own beds. The EMFIT tracker has a sensor strip that goes underneath the participant's mattress, which is connected to a small senor device that plugs into the wall near the bed, and which connects the the participant's WiFi in order to transmit sleep data. This device was used to measure heart rate, breathing rate, movement activity every 4 seconds, sleep staging every 30 seconds, and heart rate variability every 3 minutes.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Wholetones® 2Sleep Music on Health and Sleep Behaviors of Healthy Adults With Insomnia Symptoms
Official Title  ICMJE Efficacy of Wholetones® 2Sleep Music on Health and Sleep Behaviors of Healthy Adults With Insomnia Symptoms: A Single Blind Randomized Controlled Crossover Trial
Brief Summary (b) The investigators propose to conduct a four-week randomized controlled crossover trial on healthy adults with occasional sleeplessness to examine the efficacy of Wholetones music on their health-related quality of life, sleep quality and quantity, anxiety/stress levels, mood, and EMFIT sleep tracker data. Baseline sleep data will be obtained for the first week of the study. Using a crossover design, each participant will then be randomized for 10 days to each of the following two conditions: (1) Wholetones music and (2) classical music. The participants will be instructed to listed to the music for 30 minutes prior to sleep each night. The self-report assessments will be taken at Day 0 (baseline), Day 7, Day 17, Day 21, and Day 31. The participants will also complete a sleep daily survey and use the EMFIT tracker nightly. It is hypothesized that the music conditions will result in improved sleep behaviors and self-report health outcomes compared to the classical music condition. It is also hypothesized that a dose-response will be evidenced with stronger effects found for Wholetones music compared to the classical music.
Detailed Description

To determine if the Wholetones® or classical music was successful at alleviating symptoms of insomnia or sleeplessness when compared to not listening to any music, self-report data from large surveys was collected both at baseline, and during the interventions at day 17 (after the first music condition), and at day 31 (after the second music condition. Participants also completed daily diaries which was comprised of 6 questions that assessed their music adherence, sleep quality, and music likeability. These were completed daily from baseline through to the end of the study.

Objective data was also collected during baseline period of 1-week, throughout both of the interventions (10 nights each for a total of 20 nights) and the washout period (4 nights) using the EMFIT tracker. This device relies on ballistocardiography, was used to objectively assess nighttime sleep in the natural environment. This sleep tracker is automatic, autonomous, and is installed under the mattress.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Insomnia
  • Sleeplessness
Intervention  ICMJE
  • Behavioral: Wholetones Music
    Participants listened to the Wholetones music for 10 nights consecutively. Participants began playing the music 30 minutes before going to bed and were asked to allow it to play continuously throughout the night.
  • Behavioral: Classical Music
    Participants listened to the classical music for 10 nights consecutively. Participants began playing the music 30 minutes before going to bed and were asked to allow it to play continuously throughout the night.
Study Arms  ICMJE
  • Active Comparator: Wholetones Intervention

    Wholetones music to help participants sleep. Data collected after listening to the Wholetones music was compared to that collected both at Baseline, and after listening to the other music condition (i.e. Classical music).

    Wholetones® 2Sleep is music that is designed to lull the listener into a deep, delta sleep, using frequency-enhanced music and precise tempos. Wholetones® differs from other musical genres in that it employs a proprietary method of tuning and layering the music with a unique frequency underlayment.

    Intervention: Behavioral: Wholetones Music
  • Active Comparator: Classical Intervention

    Classical music was the additional music condition used to compare to both Baseline data and Wholetones data.

    The classical music was selected based on the Mayo Clinic and NIH music recommendations for better sleep. More specifically, the classical music consisted of the following six pieces: Beethoven (i.e., Moonlight Sonata, first movement), Marconi Union (i.e., Weightless), Chopin (i.e., Nocturne No.2, Op.9), Ravel (i.e., Piano Concerto in G major, 2nd movement), and J.S. Bach (i.e., Prelude No.1).

    Intervention: Behavioral: Classical Music
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2019)
44
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 12, 2019
Actual Primary Completion Date March 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Insomnia Index score indicating occasional sleeplessness

Exclusion Criteria:

  • BMI over 34
  • smokers
  • heart conditions
  • sleep apnea
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03928301
Other Study ID Numbers  ICMJE 363968-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Heather Hausenblaus, Jacksonville University
Study Sponsor  ICMJE Jacksonville University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jacksonville University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP