Using sound to improve sleep quality in people with insomnia: a pilot study
| ISRCTN | ISRCTN73971514 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73971514 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Canadian Institutes of Health Research Project Grant PJT 153115 |
| Sponsor | Duke-NUS Medical School |
| Funders | Canadian Institutes of Health Research, National Medical Research Council |
- Submission date
- 24/02/2025
- Registration date
- 04/03/2025
- Last edited
- 03/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Consistent difficulties falling asleep and/or staying asleep can lead to a diagnosis of insomnia, a common sleep disorder that impacts daytime functioning and quality of life. Neural oscillations that occur during sleep such as sleep spindles are considered individual biomarkers of sleep quality, due to a major functional role in gating of external stimuli during sleep to preserve sleep stability. Individuals suffering from chronic insomnia may benefit from alternative treatments, such as enhancing spindle activity, which has the potential to ameliorate the detrimental effects of sleep loss in patients with insomnia. In young healthy adults, auditory tones phase-locked to the brain’s endogenous oscillations have been shown to increase the amplitude of slow oscillations and in turn, boost the occurrence of sleep spindles. This pilot study thus aims to (1) test the effectiveness of increasing sleep spindle activity in adults with insomnia using a paradigm of slow oscillation enhancement through auditory tones (called closed-loop auditory stimulation; CLAS); and, (2) investigate if these changes contribute to an increase in both objective and subjective sleep quality, in addition to changes in neurocognitive performance.
Who can participate?
Patients above 21 years old meeting DSM-V diagnostic criteria for chronic insomnia
What does the study involve?
Subjects will be evaluated across three conditions, each separated by a week. These are:
(1) Adaptation night to screen for sleep disorders, record sleep EEG characteristics and acclimatization to a new sleeping environment;
(2) Stimulation night during which CLAS will be played during sleep, and;
(3) Sham night, during which no tones are played.
Questionnaires and cognitive tasks will be administered before and after sleep in (2) and (3) to assess the efficacy of stimulation on sleep quality and cognition. The order of sessions 2 and 3 will be counterbalanced.
What are the possible benefits and risks of participating?
There is no direct benefit from this study. However, their voluntary participation will contribute to the better understanding of human brain function towards sleep quality and memory consolidation during sleep.
Possible risks may concern the EEG component: adhesive tape/paste are used to attach electrodes. In rare cases, this could cause some minor skin irritation or acne. Such discomfort is monitored and may be removed if necessary.
Where is the study run from?
Duke-NUS Medical School, Singapore
When is the study starting and how long is it expected to run for?
January 2018 to August 2019
Who is funding the study?
1. National Medical Research Council (NMRC) Singapore
2. Canadian Institutes of Health Research
Who is the main contact?
Prof Thien Thanh Dang Vu, tt.dangvu@concordia.ca
Contact information
Public, Scientific, Principal investigator
Dpt of Health, Kinesiology and Applied Physiology, Concordia University
7141 Sherbrooke St. West, SP 165.27
Montreal
H4B 1R6
Canada
 ORCID ID |
0000-0002-7235-2721 |
|---|---|
| Phone | +1 (514) 848-2424, Ext 3364 |
| tt.dangvu@concordia.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized crossover sham-controlled study |
| Secondary study design | Randomised cross over trial |
| Participant information sheet | 46890_PIS_V1.2_15January2018.pdf |
| Scientific title | Auditory entrainment of sleep spindles and the impact on sleep quality in insomniacs: a pilot study |
| Study objectives | Auditory closed-loop stimulation (CLAS) will increase spindle activity compared to SHAM night. The increase in spindle density will be correlated with increased sleep efficiency, subjective sleep quality and better overnight memory performance. |
| Ethics approval(s) |
Approved 23/01/2018, National University of Singapore Institutional Review Board (10 Medical Drive, Singapore, 117597, Singapore; 65-6516 4311; irb@nus.edu.sg), ref: H-18-004 |
| Health condition(s) or problem(s) studied | Insomnia disorder |
| Intervention | 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 polysomnographic (PSG) recording in a counterbalanced order: one with closed-loop auditory stimulation (CLAS) stimulation and one without stimulation (SHAM). There are 7 days between each night. All nights took place in the laboratory CLAS: Real-time automated sleep stage detection and up-state targeting of slow oscillations (SOs) is used during N2 and N3 on electrode F3:A2. Auditory tones (50ms bursts of pink noise) locked to SO upstates are played in 2-ON-OFF blocks. Tone presentation is halted if an arousal occurs or if voltage thresholds (40uV) are not met. This intervention has been used previously by the host team (Singapore) (see Ong et al., Sleep Medicine 2016; 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 detected but no tones is played. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Auditory closed-loop stimulation (CLAS) |
| Primary outcome measure(s) |
Spindle activity (including spindle density, amplitude, duration, and peak frequency) is measured using automatic spindle detection during SHAM and STIM nights |
| Key secondary outcome measure(s) |
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 |
| Completion date | 05/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 21 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 10 |
| Total final enrolment | 27 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 13/02/2018 |
| Date of final enrolment | 05/08/2019 |
Locations
Countries of recruitment
- Singapore
Study participating centre
Singapore
169857
Singapore
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Prof Thien Thanh Dang Vu (tt.dangvu@concordia.ca) • The type of data that will be shared : coded EEG raw dataset and memory performances • Timing for availability: once manuscript in published (expected end of 2025) • Whether consent from participants was required and obtained : yes • Comments on data anonymization: coded - no identifiable information (i.e., name, email address and contact number) can be shared • Any ethical or legal restrictions: no identifiable information can be shared |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.2 | 15/01/2018 | 03/03/2025 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 46890_PIS_V1.2_15January2018.pdf
- Participant information sheet
Editorial Notes
25/02/2025: Study's existence confirmed by the National University of Singapore Institutional Review Board.
