Music for Sleep-onset Insomnia

University of Aarhus

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Bedtime music listening; Behavioral: Sleep hygiene advice

Study type: Interventional

Funder types: Other

Identifiers

NCT04585425

M&I2020

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Control

Other group

Description:

Treatment as usual including sleep hygiene advice

Treatment:

Behavioral: Sleep hygiene advice

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Sleep hygiene advice

Behavioral: Bedtime music listening