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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03928301
• Other study ID #: 363968-1
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: March 12, 2019

Study information

• Verified date: April 2019
• Source: Jacksonville University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 12, 2019
• Est. primary completion date: March 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Insomnia Index score indicating occasional sleeplessness

Exclusion Criteria:

• BMI over 34

• smokers

• heart conditions

• sleep apnea

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders
• Sleeplessness

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Jacksonville University	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Jacksonville University

Country where clinical trial is conducted

United States, 

References & Publications (11)

Ancoli-Israel S, Roth T. Characteristics of insomnia in the United States: results of the 1991 National Sleep Foundation Survey. I. Sleep. 1999 May 1;22 Suppl 2:S347-53. — View Citation

Buysse DJ, Ancoli-Israel S, Edinger JD, Lichstein KL, Morin CM. Recommendations for a standard research assessment of insomnia. Sleep. 2006 Sep;29(9):1155-73. Review. Erratum in: Sleep. 2006 Nov 1;29(11):1380. — View Citation

Chang ET, Lai HL, Chen PW, Hsieh YM, Lee LH. The effects of music on the sleep quality of adults with chronic insomnia using evidence from polysomnographic and self-reported analysis: a randomized control trial. Int J Nurs Stud. 2012 Aug;49(8):921-30. doi: 10.1016/j.ijnurstu.2012.02.019. Epub 2012 Apr 10. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

de Niet G, Tiemens B, Lendemeijer B, Hutschemaekers G. Music-assisted relaxation to improve sleep quality: meta-analysis. J Adv Nurs. 2009 Jul;65(7):1356-64. doi: 10.1111/j.1365-2648.2009.04982.x. Epub 2009 Apr 28. Review. — View Citation

Feng F, Zhang Y, Hou J, Cai J, Jiang Q, Li X, Zhao Q, Li BA. Can music improve sleep quality in adults with primary insomnia? A systematic review and network meta-analysis. Int J Nurs Stud. 2018 Jan;77:189-196. doi: 10.1016/j.ijnurstu.2017.10.011. Epub 2017 Oct 23. Review. — View Citation

Harmat L, Takács J, Bódizs R. Music improves sleep quality in students. J Adv Nurs. 2008 May;62(3):327-35. doi: 10.1111/j.1365-2648.2008.04602.x. — View Citation

Huang CY, Chang ET, Lai HL. Comparing the effects of music and exercise with music for older adults with insomnia. Appl Nurs Res. 2016 Nov;32:104-110. doi: 10.1016/j.apnr.2016.06.009. Epub 2016 Jun 23. — View Citation

Jespersen KV, Koenig J, Jennum P, Vuust P. Music for insomnia in adults. Cochrane Database Syst Rev. 2015 Aug 13;(8):CD010459. doi: 10.1002/14651858.CD010459.pub2. Review. — View Citation

Jespersen KV, Otto M, Kringelbach M, Van Someren E, Vuust P. A randomized controlled trial of bedtime music for insomnia disorder. J Sleep Res. 2019 Jan 24:e12817. doi: 10.1111/jsr.12817. [Epub ahead of print] — View Citation

Trahan T, Durrant SJ, Müllensiefen D, Williamson VJ. The music that helps people sleep and the reasons they believe it works: A mixed methods analysis of online survey reports. PLoS One. 2018 Nov 14;13(11):e0206531. doi: 10.1371/journal.pone.0206531. eCollection 2018. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change In Pittsburgh Sleep Quality Index Scores from Baseline to those at Days 17 & 31	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.	Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition)
Primary	Change In Profile of Mood States (POMS) Scores from Baseline to Days 17 & 31	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.	Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition)
Primary	Change in State Trait Anxiety Inventory Scores from Baseline to Days 17 & 31	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.	Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition)
Primary	Change In Perceived Stress Scale Scores at Baseline from Days 17 & 31	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.	Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition)
Primary	Change In Flinder's Fatigue Scale Scores from Baseline to Days 17 & 31	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.	Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition)
Primary	Change In Productivity Scores from Baseline to Days 17 & 31	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.	Day 0, Day 17 (following 10 days of one music condition), Day 31 (following 10 days of second music condition)
Primary	EMFIT Sleep Tracker data	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.	This data was collected for the 1-month duration of the study (7 days of baseline, 20 days of intervention, 4 days of washout).