InsomniaNCT02321826
Music for Insomnia
A study testing Music and Audiobook in people with Insomnia and Sleep Disorders, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia, Sleep Disorders
- What is being tested?
- Music and Audiobook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2015to 29 Sep 2017
- 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
- Insomnia diagnosis
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Better Night - Better Day: a Randomized Controlled Trial of Listening to Music for Improving Insomnia
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.
Read the 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.
- Conditions
- Insomnia, Sleep Disorders
- Being tested
- Music, Audiobook
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
Participants choice among 4 genres of music matched on music characteristics
AudiobookBehavioural
Participants choice among 4 types of audiobooks
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Listening to music for 45 minutes at bedtime Receives: Behavioral: Music |
| Audiobook | Active comparator | Listening to audiobook for 45 minutes at bedtime Receives: Behavioral: Audiobook |
| Control | No intervention | No intervention control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insomnia severity
Measured with the Insomnia Severity Index (ISI)
Measured: Baseline and three-weeks follow-up
Change in subjective sleep quality
Measured with the Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline and three-weeks follow-up
Secondary outcomes (4)
Change in objective sleep quality (PSG)
Total sleep time, Sleep efficiency, sleep onset latency and wake after sleep onset as measured with polysomnography
Measured: Baseline and three-weeks follow-up
Change in objective sleep quality (actigraphy)
Total sleep time, Sleep efficiency, sleep onset latency and wake after sleep onset as measured with actigraphy
Measured: Baseline and three-weeks follow-up
Change in daytime dysfunction
Measured with the Fatigue severity scale (FSS), Becks Depression inventory (BDI-II), State-Trait Anxiety Inventory (STAI) and WHOQOL-BREF
Measured: Baseline and three-weeks follow-up
Change in physiological arousal
Measured with ECG and respiration rate
Measured: Baseline and three-weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startApr 2015
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Kira V Jespersen, Principal investigator, Center of Functionally Integrative Neuroscience, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321826
- Sponsor's protocol ID
- M&I2015
- Status last verified
- Apr 2017
- First submitted
- 10 Dec 2014
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Night - Better Day: a Randomized Controlled Trial of Listening to Music for Improving Insomnia
- ClinicalTrials.gov ID
- NCT02321826
- Acronym / sponsor ID
- M&I2015
- Conditions
- Insomnia, Sleep Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Apr 2015
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 22 Dec 2014 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Behavioral: MusicListening to music for 45 minutes at bedtime |
| Audiobook | Active comparator | Behavioral: AudiobookListening to audiobook for 45 minutes at bedtime |
| Control | No intervention | –No intervention control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Insomnia diagnosis
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| MusicParticipants choice among 4 genres of music matched on music characteristics | Behavioural | Music |
| AudiobookParticipants choice among 4 types of audiobooks | Behavioural | Audiobook |
Primary outcome
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)
4 secondary outcomes
Change in objective sleep quality (PSG)
Time frame: Baseline and three-weeks follow-up
Change in objective sleep quality (actigraphy)
Time frame: Baseline and three-weeks follow-up
Change in daytime dysfunction
Time frame: Baseline and three-weeks follow-up
Change in physiological arousal
Time frame: Baseline and three-weeks follow-up
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 3 Oct 2017.
- 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 principal investigator
Center of Functionally Integrative Neuroscience, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and Audiobook in people with Insomnia and Sleep Disorders, 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 5 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 3 Oct 2017. 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?
Change in insomnia severity (time frame: Baseline and three-weeks follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2017.