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Using sound to improve sleep quality in people with insomnia: a pilot study

Auditory entrainment of sleep spindles and the impact on sleep quality in insomniacs: a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN73971514
Enrollment
10
Registered
2025-03-04
Start date
2018-02-13
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia disorder Nervous System Diseases

Interventions

Auditory closed-loop stimulation (CLAS). The study uses a randomized crossover sham-controlled study so all participants undergo a habituation night followed by two experimental nights with polysomno
Ong et al., SLEEP, 2018) SHAM: Real-time automated sleep stage detection and up-state targeting of slow oscillations (SOs) is used during N2 and N3 on electrode F3:A2. The SO up-state locations are d

Sponsors

Duke-NUS Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Above 21 years 2. Meeting DSM-V diagnostic criteria for chronic insomnia 3. English as a first language 4. Have a minimum of 12 years of formal education 5. Have consistent sleeping habits at least 7 days prior to the study 6. Not be on any long-term medications affecting sleep 7. No other known medical conditions than insomnia that could affect sleep 8. Consume less than 2 units (200mg) of caffeine a day 9. Consume less than 21 units of alcohol per week 10. Score at the mini-mental state examination should be = 26 if = 55 years old

Exclusion criteria

Exclusion criteria: 1. History of any psychiatric or neurological disorders 2. History of severe medical illnesses 3. Shift workers 4. Save travelled across more than 1 time zone one month prior to the study 5. Not taking any psychoactive medication 1 week prior to or during the study

Design outcomes

Primary

MeasureTime frame
Spindle activity (including spindle density, amplitude, duration, and peak frequency) is measured using automatic spindle detection during SHAM and STIM nights

Secondary

MeasureTime frame
1. Sleep macro-architecture (total sleep time (min), time in bed (min), wake after sleep onset (min), sleep onset latency (min), sleep efficiency (%; total sleep time/time in bed*100), time spent in each stage (%total sleep period), sleep fragmentation index (n/h)) measured using data extracted from sleep scoring during SHAM and STIM nights 2. Arousal index (n/h) measured using data extracted from manual detection of arousal during SHAM and STIMS 3. Slow oscillatory activity (<1.25Hz; including density, amplitude, and peak frequency) is measured using automatic SO detection during SHAM and STIM nights 4. Delta power (0.25-4Hz) is measured using Fast Fourier Transformation on frontal derivations during SHAM and STIM nights 5. Self-reported sleep assessment (including sleep quality rating, sleep duration, and number of awakenings) measured using data extracted from the questionnaire in the morning after STIM and SHAM nights 6. Declarative memory accuracy (correct minus wrong) measured using data extracted from the performance at the word paired-associate learning task performed before and after sleep during SHAM and STIM nights

Countries

Singapore

Contacts

Public ContactThien Thanh Dang Vu
tt.dangvu@concordia.ca+1 (514) 848-2424, Ext 3364

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026