Efficacy of Wholetones® 2Sleep Music on Health and Sleep Behaviors of Healthy Adults With Insomnia Symptoms
Condition: Insomnia; Sleeplessness
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

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.
    

Intervention name(s): Wholetones Music; Classical Music
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research