InsomniaNCT04585425
Music for Sleep-onset Insomnia
A study testing Sleep hygiene advice and Bedtime music listening in people with Insomnia, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Sleep hygiene advice and Bedtime music listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2021to 2 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sleep-onset insomnia for 3-18 months
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: God Nat - God Dag. A Randomized Controlled Trial of Bedtime Music as Early Intervention for Sleep-onset Insomnia
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.
- Conditions
- Insomnia
- Being tested
- Sleep hygiene advice, Bedtime music listening
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep hygiene adviceBehavioural
Participants receive standard sleep hygiene advice.
Bedtime music listeningBehavioural
Participants in the intervention group listen to their preferred sleep playlist daily at bedtime for minimum 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Treatment as usual including sleep hygiene advice Receives: Behavioral: Sleep hygiene advice |
| Intervention | Experimental | Treatment as usual (sleep hygiene advice) and bedtime music listening Receives: Behavioral: Sleep hygiene advice; Behavioral: Bedtime music listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity
Measured with the Insomnia Severity Index, range 0-28 with higher scores indicating more severe insomnia.
Measured: Change from baseline to after the 4-week intervention period.
Secondary outcomes (6)
Sleep quality
Measured with the Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating more sleep problems.
Measured: Change from baseline to after the 4-week intervention period.
Sleep initiation difficulties
Difficulties initiating sleep as measured with Pittsburgh Sleep Quality Index subscale
Measured: Change from baseline to after the 4-week intervention period.
Objective sleep quality
Objective sleep quality as measured with polysomnography
Measured: Change from baseline to after the 4-week intervention period.
Sleep-wake pattern
Sleep-wake pattern as measured with wrist-actigraphy
Measured: Change from baseline to after the 4-week intervention period.
Quality of life
Quality of life as measured with SF-36, range 0-100 with higher scores indicating better quality of life.
Measured: Change from baseline to after the 4-week intervention period.
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.
Measured: Change from baseline to after the 4-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 May 2021
- Primary completion10 Apr 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg, University College Nordjylland, University of Oxford, Sygekassernes Helsefond
- Responsible party
- Sponsor
- Investigators
- Kira V Jespersen, PhD, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585425
- Sponsor's protocol ID
- M&I2020
- Status last verified
- Dec 2023
- First submitted
- 29 Sep 2020
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36000763
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- God Nat - God Dag. A Randomized Controlled Trial of Bedtime Music as Early Intervention for Sleep-onset Insomnia
- ClinicalTrials.gov ID
- NCT04585425
- Acronym / sponsor ID
- M&I2020
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg, University College Nordjylland, University of Oxford, Sygekassernes Helsefond
- Study start
- 1 May 2021 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Behavioral: Sleep hygiene adviceTreatment as usual including sleep hygiene advice |
| Intervention | Experimental | Behavioral: Sleep hygiene advice, Behavioral: Bedtime music listeningTreatment as usual (sleep hygiene advice) and bedtime music listening |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sleep-onset insomnia for 3-18 months
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep hygiene adviceParticipants receive standard sleep hygiene advice. | Behavioural | Control, Intervention |
| Bedtime music listeningParticipants in the intervention group listen to their preferred sleep playlist daily at bedtime for minimum 30 minutes. | Behavioural | Intervention |
Primary outcome
Insomnia severity
Time frame: Change from baseline to after the 4-week intervention period.
Measured with the Insomnia Severity Index, range 0-28 with higher scores indicating more severe insomnia.
6 secondary outcomes
Sleep quality
Time frame: Change from baseline to after the 4-week intervention period.
Sleep initiation difficulties
Time frame: Change from baseline to after the 4-week intervention period.
Objective sleep quality
Time frame: Change from baseline to after the 4-week intervention period.
Sleep-wake pattern
Time frame: Change from baseline to after the 4-week intervention period.
Quality of life
Time frame: Change from baseline to after the 4-week intervention period.
Pre-sleep arousal
Time frame: Change from baseline to after the 4-week intervention period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Derived from this study: PubMed 36000763Jespersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kira V Jespersen, PhD study director
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep hygiene advice and Bedtime music listening in people with Insomnia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity (time frame: Change from baseline to after the 4-week intervention period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04585425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.