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Clinical Trials/NCT02321826
NCT02321826
Completed
Not Applicable

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

University of Aarhus1 site in 1 country57 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insomnia
Sponsor
University of Aarhus
Enrollment
57
Locations
1
Primary Endpoint
Change in insomnia severity
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
September 29, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Change in insomnia severity

Time Frame: Baseline and three-weeks follow-up

Measured with the Insomnia Severity Index (ISI)

Change in subjective sleep quality

Time Frame: 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)
  • Change in objective sleep quality (actigraphy)(Baseline and three-weeks follow-up)
  • Change in daytime dysfunction(Baseline and three-weeks follow-up)
  • Change in physiological arousal(Baseline and three-weeks follow-up)

Study Sites (1)

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