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Music for Insomnia

NCT ID: NCT02321826

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-09-29

Brief Summary

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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

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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.

Conditions

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Insomnia Sleep Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Music

Listening to music for 45 minutes at bedtime

Group Type EXPERIMENTAL

Music

Intervention Type BEHAVIORAL

Participants choice among 4 genres of music matched on music characteristics

Audiobook

Listening to audiobook for 45 minutes at bedtime

Group Type ACTIVE_COMPARATOR

Audiobook

Intervention Type BEHAVIORAL

Participants choice among 4 types of audiobooks

Control

No intervention control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music

Participants choice among 4 genres of music matched on music characteristics

Intervention Type BEHAVIORAL

Audiobook

Participants choice among 4 types of audiobooks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kira V Jespersen

Role: PRINCIPAL_INVESTIGATOR

Center of Functionally Integrative Neuroscience, Aarhus University

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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M&I2015

Identifier Type: -

Identifier Source: org_study_id