Music for Insomnia

NCT02321826 — Not applicable, Completed, 57 participants, University of Aarhus

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

Registry	NCT02321826
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	57 (Actual)
Sponsor	University of Aarhus (Other); collaborators: Aarhus University Hospital
Conditions	Insomnia, Sleep Disorders
Interventions	Music, Audiobook (Behavioral)
Dates	start 2015-04-01, primary completion 2017-09-29, completion 2017-09-29, first posted 2014-12-22, last updated 2017-10-03
Locations	1 site in Denmark

-Summary

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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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Music	Experimental	Behavioral: Music	Listening to music for 45 minutes at bedtime
Audiobook	Active comparator	Behavioral: Audiobook	Listening to audiobook for 45 minutes at bedtime
Control	No intervention		No intervention control group

Music (Behavioral): Participants choice among 4 genres of music matched on music characteristics
Audiobook (Behavioral): Participants choice among 4 types of audiobooks

+Outcome measures

Primary outcomes

Change in insomnia severity [Baseline and three-weeks follow-up]: Measured with the Insomnia Severity Index (ISI)
Change in subjective sleep quality [Baseline and three-weeks follow-up]: Measured with the Pittsburgh Sleep Quality Index (PSQI)

Secondary outcomes

Change in objective sleep quality (PSG) [Baseline and three-weeks follow-up]: Total sleep time, Sleep efficiency, sleep onset latency and wake after sleep onset as measured with polysomnography
Change in objective sleep quality (actigraphy) [Baseline and three-weeks follow-up]: Total sleep time, Sleep efficiency, sleep onset latency and wake after sleep onset as measured with actigraphy
Change in daytime dysfunction [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
Change in physiological arousal [Baseline and three-weeks follow-up]: Measured with ECG and respiration rate

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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)

+Locations (1)

Facility	City	Country	Status
Aarhus University Hospital	Aarhus	Denmark

+Investigators

Kira V Jespersen, Principal investigator, Center of Functionally Integrative Neuroscience, Aarhus University