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Completed

NCT Number: NCT02321826

Music for Insomnia

The aim of this study is to determine the effect of listening to music on sleep quality (subjective and objective), daytime dysfunction and neurophysiological arousal in patients with insomnia.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

Sleep problems are highly prevalent in modern society and poor sleep is associated with impaired physical and mental health with large costs for both individuals and society. Pharmacological treatment is recommended only for short-term use, and there is a need to study promising drug-free aids to improve sleep. Furthermore, the mechanisms of insomnia are not well understood. In the present project we will investigate if listening to music can improve sleep quality in persons suffering from insomnia. We will use a randomized controlled trial design including both subjective and objective measures of sleep.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Insomnia diagnosis

Exclusion criteria

  • Use of hypnotic medications
  • Alcohol or substance abuse
  • Pregnant or breastfeeding women
  • Sleep apnea with an apnea hypopnea index (AHI) >15
  • Clinically significant restless leg syndrome or periodic limp movement disorder (PLMS>25)

Treatment and study plan

Music

Behavioral

Participants choice among 4 genres of music matched on music characteristics

Audiobook

Behavioral

Participants choice among 4 types of audiobooks

Primary outcomes

  1. Change in insomnia severity

    Time frame: Baseline and three-weeks follow-up

    Measured with the Insomnia Severity Index (ISI)

  2. Change in subjective sleep quality

    Time frame: Baseline and three-weeks follow-up

    Measured with the Pittsburgh Sleep Quality Index (PSQI)

Secondary outcomes

  1. Change in objective sleep quality (PSG)

    Time frame: Baseline and three-weeks follow-up

    Total sleep time, Sleep efficiency, sleep onset latency and wake after sleep onset as measured with polysomnography

  2. Change in objective sleep quality (actigraphy)

    Time frame: Baseline and three-weeks follow-up

    Total sleep time, Sleep efficiency, sleep onset latency and wake after sleep onset as measured with actigraphy

  3. Change in daytime dysfunction

    Time frame: Baseline and three-weeks follow-up

    Measured with the Fatigue severity scale (FSS), Becks Depression inventory (BDI-II), State-Trait Anxiety Inventory (STAI) and WHOQOL-BREF

  4. Change in physiological arousal

    Time frame: Baseline and three-weeks follow-up

    Measured with ECG and respiration rate

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

Better Night - Better Day: a Randomized Controlled Trial of Listening to Music for Improving Insomnia

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 22, 2014
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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