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Music for Sleep-onset Insomnia

Primary Purpose

Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Sleep hygiene advice
Bedtime music listening
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:

  • Sleep-onset insomnia for 3-18 months

Exclusion Criteria:

  1. use of medications (benzodiazepines, z-drugs, antidepressive and anti-psychotic drugs)
  2. alcohol or substance abuse
  3. pregnant or breastfeeding women
  4. other sleep disorders (e.g. sleep apnea, restless leg syndrome, etc.)
  5. current psychiatric disorder or a history of psychotic disorders
  6. somatic disorders interfering with sleep (e.g. critical illness, pain disorders, neuro-degenerative disorders)
  7. shift work.

Sites / Locations

  • Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Intervention

Arm Description

Treatment as usual including sleep hygiene advice

Treatment as usual (sleep hygiene advice) and bedtime music listening

Outcomes

Primary Outcome Measures

Insomnia severity
Measured with the Insomnia Severity Index, range 0-28 with higher scores indicating more severe insomnia.

Secondary Outcome Measures

Sleep quality
Measured with the Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating more sleep problems.
Sleep initiation difficulties
Difficulties initiating sleep as measured with Pittsburgh Sleep Quality Index subscale
Objective sleep quality
Objective sleep quality as measured with polysomnography
Sleep-wake pattern
Sleep-wake pattern as measured with wrist-actigraphy
Quality of life
Quality of life as measured with SF-36, range 0-100 with higher scores indicating better quality of life.
Pre-sleep arousal
Pre-sleep arousal as measured with the Pre-Sleep Arousal Scale, range 8-40 with higher scores indicating higher pre-sleep arousal.

Full Information

First Posted
September 29, 2020
Last Updated
October 18, 2022
Sponsor
University of Aarhus
Collaborators
University Hospital Heidelberg, University College Nordjylland, University of Oxford, Sygekassernes Helsefond
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1. Study Identification

Unique Protocol Identification Number
NCT04585425
Brief Title
Music for Sleep-onset Insomnia
Official Title
God Nat - God Dag. A Randomized Controlled Trial of Bedtime Music as Early Intervention for Sleep-onset Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
University Hospital Heidelberg, University College Nordjylland, University of Oxford, Sygekassernes Helsefond

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study is a randomized controlled trial evaluating the effect of bedtime music as an early intervention for sleep-onset insomnia in adults. The investigators use a randomized controlled trial design with two parallel groups. All participants receive sleep hygiene advice as standard treatment and participants in the intervention group are additionally asked to listen to a sleep playlist daily at bedtime. Subjective and objective sleep measures are evaluated before and after the 4 weeks intervention period. In addition, follow-up measures of subjective outcomes are assessed 4 weeks after the end of the intervention period.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Treatment as usual including sleep hygiene advice
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Treatment as usual (sleep hygiene advice) and bedtime music listening
Intervention Type
Behavioral
Intervention Name(s)
Sleep hygiene advice
Intervention Description
Participants receive standard sleep hygiene advice.
Intervention Type
Behavioral
Intervention Name(s)
Bedtime music listening
Intervention Description
Participants in the intervention group listen to their preferred sleep playlist daily at bedtime for minimum 30 minutes.
Primary Outcome Measure Information:
Title
Insomnia severity
Description
Measured with the Insomnia Severity Index, range 0-28 with higher scores indicating more severe insomnia.
Time Frame
Change from baseline to after the 4-week intervention period.
Secondary Outcome Measure Information:
Title
Sleep quality
Description
Measured with the Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating more sleep problems.
Time Frame
Change from baseline to after the 4-week intervention period.
Title
Sleep initiation difficulties
Description
Difficulties initiating sleep as measured with Pittsburgh Sleep Quality Index subscale
Time Frame
Change from baseline to after the 4-week intervention period.
Title
Objective sleep quality
Description
Objective sleep quality as measured with polysomnography
Time Frame
Change from baseline to after the 4-week intervention period.
Title
Sleep-wake pattern
Description
Sleep-wake pattern as measured with wrist-actigraphy
Time Frame
Change from baseline to after the 4-week intervention period.
Title
Quality of life
Description
Quality of life as measured with SF-36, range 0-100 with higher scores indicating better quality of life.
Time Frame
Change from baseline to after the 4-week intervention period.
Title
Pre-sleep arousal
Description
Pre-sleep arousal as measured with the Pre-Sleep Arousal Scale, range 8-40 with higher scores indicating higher pre-sleep arousal.
Time Frame
Change from baseline to after the 4-week intervention period.
Other Pre-specified Outcome Measures:
Title
Depressive symptoms
Description
Depressive symptoms as measured with Beck Depression Inventory II, range 0-63 with higher scores indicating more severe depression.
Time Frame
Change from baseline to after the 4-week intervention period.
Title
Anxiety
Description
Anxiety as measured with the State-Trait Anxiety Inventory, range 0-80 with higher scores indicating more anxiety.
Time Frame
Change from baseline to after the 4-week intervention period.

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: Sleep-onset insomnia for 3-18 months Exclusion Criteria: use of medications (benzodiazepines, z-drugs, antidepressive and anti-psychotic drugs) alcohol or substance abuse pregnant or breastfeeding women other sleep disorders (e.g. sleep apnea, restless leg syndrome, etc.) current psychiatric disorder or a history of psychotic disorders somatic disorders interfering with sleep (e.g. critical illness, pain disorders, neuro-degenerative disorders) shift work.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kira V Jespersen, PhD
Email
kira@clin.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kira V Jespersen, PhD
Organizational Affiliation
University of Aarhus
Official's Role
Study Director
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kira V Jespersen, PhD
Phone
+4578469933
Email
kira@cfin.au.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36000763
Citation
Jespersen KV, Pando-Naude V, Koenig J, Jennum P, Vuust P. Listening to music for insomnia in adults. Cochrane Database Syst Rev. 2022 Aug 24;8(8):CD010459. doi: 10.1002/14651858.CD010459.pub3.
Results Reference
derived

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Music for Sleep-onset Insomnia

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