search
Back to results

Music for Insomnia

Primary Purpose

Insomnia, Sleep Disorders

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Music
Audiobook
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Music

Audiobook

Control

Arm Description

Listening to music for 45 minutes at bedtime

Listening to audiobook for 45 minutes at bedtime

No intervention control group

Outcomes

Primary Outcome Measures

Change in insomnia severity
Measured with the Insomnia Severity Index (ISI)
Change in subjective sleep quality
Measured with the Pittsburgh Sleep Quality Index (PSQI)

Secondary Outcome Measures

Change in objective sleep quality (PSG)
Total sleep time, Sleep efficiency, sleep onset latency and wake after sleep onset as measured with polysomnography
Change in objective sleep quality (actigraphy)
Total sleep time, Sleep efficiency, sleep onset latency and wake after sleep onset as measured with actigraphy
Change in daytime dysfunction
Measured with the Fatigue severity scale (FSS), Becks Depression inventory (BDI-II), State-Trait Anxiety Inventory (STAI) and WHOQOL-BREF
Change in physiological arousal
Measured with ECG and respiration rate

Full Information

First Posted
December 10, 2014
Last Updated
September 29, 2017
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02321826
Brief Title
Music for Insomnia
Official Title
Better Night - Better Day: a Randomized Controlled Trial of Listening to Music for Improving Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 29, 2017 (Actual)
Study Completion Date
September 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Sleep Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music
Arm Type
Experimental
Arm Description
Listening to music for 45 minutes at bedtime
Arm Title
Audiobook
Arm Type
Active Comparator
Arm Description
Listening to audiobook for 45 minutes at bedtime
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention control group
Intervention Type
Behavioral
Intervention Name(s)
Music
Intervention Description
Participants choice among 4 genres of music matched on music characteristics
Intervention Type
Behavioral
Intervention Name(s)
Audiobook
Intervention Description
Participants choice among 4 types of audiobooks
Primary Outcome Measure Information:
Title
Change in insomnia severity
Description
Measured with the Insomnia Severity Index (ISI)
Time Frame
Baseline and three-weeks follow-up
Title
Change in subjective sleep quality
Description
Measured with the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Baseline and three-weeks follow-up
Secondary Outcome Measure Information:
Title
Change in objective sleep quality (PSG)
Description
Total sleep time, Sleep efficiency, sleep onset latency and wake after sleep onset as measured with polysomnography
Time Frame
Baseline and three-weeks follow-up
Title
Change in objective sleep quality (actigraphy)
Description
Total sleep time, Sleep efficiency, sleep onset latency and wake after sleep onset as measured with actigraphy
Time Frame
Baseline and three-weeks follow-up
Title
Change in daytime dysfunction
Description
Measured with the Fatigue severity scale (FSS), Becks Depression inventory (BDI-II), State-Trait Anxiety Inventory (STAI) and WHOQOL-BREF
Time Frame
Baseline and three-weeks follow-up
Title
Change in physiological arousal
Description
Measured with ECG and respiration rate
Time Frame
Baseline and three-weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kira V Jespersen
Organizational Affiliation
Center of Functionally Integrative Neuroscience, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Music for Insomnia

We'll reach out to this number within 24 hrs