Efficacy of Wholetones® 2Sleep Music on Health and Sleep Behaviors of Healthy Adults With Insomnia Symptoms
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| ClinicalTrials.gov Identifier: NCT03928301 |
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Recruitment Status :
Completed
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Insomnia Sleeplessness | Behavioral: Wholetones Music Behavioral: Classical Music | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 44 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Health Services Research |
| Official Title: | Efficacy of Wholetones® 2Sleep Music on Health and Sleep Behaviors of Healthy Adults With Insomnia Symptoms: A Single Blind Randomized Controlled Crossover Trial |
| Actual Study Start Date : | January 15, 2019 |
| Actual Primary Completion Date : | March 12, 2019 |
| Actual Study Completion Date : | March 12, 2019 |
| Arm | Intervention/treatment |
|---|---|
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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. |
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. |
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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). |
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. |
- 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.
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| Ages Eligible for Study: | 25 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Insomnia Index score indicating occasional sleeplessness
Exclusion Criteria:
- BMI over 34
- smokers
- heart conditions
- sleep apnea
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928301
| United States, Florida | |
| Jacksonville University | |
| Jacksonville, Florida, United States, 32211 | |
Other Publications:
| Responsible Party: | Dr. Heather Hausenblaus, Lead Investigator, Jacksonville University |
| ClinicalTrials.gov Identifier: | NCT03928301 |
| Other Study ID Numbers: |
363968-1 |
| First Posted: | April 26, 2019 Key Record Dates |
| Last Update Posted: | April 26, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Wake Disorders Nervous System Diseases Mental Disorders |