Insomnia Mental and Behavioural Disorders Nonorganic insomnia
Conditions
Interventions
Interested participants will be screened for suitability through an online questionnaire and a telephone interview with a member of the research team. Once eligibility has been determined, and consent
one night with cathodal tDCS and one night with sham stimulation prior to the sleep period (order of nights is randomised). Participants will be randomly allocated to treatment order (real stimulation
sham first then real stimulation) in a counterbalanced manner. This is a double-blind study
the experimenter will also be blind to the stimulation delivered.
Prior to sleep, participants will undergo 20 min of cathodal transcranial direct current stimulation (bifrontal stimu
max 2mA
current will be ramped up over 10 s, held for 20 min, and then ramped down over 10 s) or sham stimulation (current will be ramped up over 10 s and then switched off
standard protocol for credible tDCS sham stimulation).
Prior to the study nights, participants will wear an actimeter and complete a sleep diary. During the study nights, polysomnogra
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 11/03/2020: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18-65 years 3. Screening positive for persistent insomnia (chronicity >3 months) as indicated on the Sleep Condition Indicator 4. Sleep onset difficulties with or without sleep maintenance problems 5. Increased pre-sleep arousal (pre-sleep arousal scale) 6. Score = 2 on the Sleep Condition Indicator questions 5 or 6 (daytime impairment) 7. Typical sleep period takes place within the hours of 10 pm – 9 am 8. Can read and understand English 9. Normal or corrected to normal vision (visual, computer-based, tasks comprise part of the experiment) _____ Previous inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 25-65 years 3. Screening positive for persistent insomnia (chronicity >3 months) as indicated on the Sleep Condition Indicator 4. Sleep onset difficulties with or without sleep maintenance problems 5. Increased pre-sleep arousal (pre-sleep arousal scale) 6. Score = 2 on the Sleep Condition Indicator questions 5 or 6 (daytime impairment) 7. Typical sleep period takes place within the hours of 10 pm – 9 am 8. Can read and understand English 9. Normal or corrected to normal vision (visual, computer-based, tasks comprise part of the experiment) 10. Right handed
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 11/03/2020: 1. Unstable physical or mental health problems that may explain sleep disturbance 2. Probable additional sleep disorders (e.g. sleep-disordered breathing or periodic leg movements during sleep assessed via questionnaire and interview) 3. Habitual night shift, evening, or rotating shift-workers 4. Undergoing a psychological treatment programme for insomnia with a health professional 5. Medication use (central nervous system agents including hypnotics) 6. Previous participation in tDCS study 7. Substance abuse 8. Pregnancy 9. Psychosis or epilepsies 10. A score within the clinical range for depression (>14) or anxiety (>14) on Hospital Anxiety and Depression Questionnaire (HADS) 11. Learning disability 12. Skin allergies or very sensitive skin 13. Diagnosis of a neurological condition (e.g. epilepsy, stroke, multiple sclerosis) 14. Contraindications to tDCS (including, but not limited to metal in the head or medical devices implanted in the brain, epilepsy) _____ Previous exclusion criteria: 1. Unstable physical or mental health problems that may explain sleep disturbance 2. Probable additional sleep disorders (e.g. sleep-disordered breathing or periodic leg movements during sleep assessed via questionnaire and interview) 3. Habitual night shift, evening, or rotating shift-workers 4. Undergoing a psychological treatment programme for insomnia with a health professional 5. Medication use (central nervous system agents including hypnotics) 6. Previous participation in tDCS study 7. Substance abuse 8. Pregnancy 9. Psychosis or epilepsies 10. A score within the clinical range for depression (>7) or anxiety (>10) on Hospital Anxiety and Depression Questionnaire (HADS) 11. Learning disability 12. Skin allergies or very sensitive skin 13. Diagnosis of a neurological condition (e.g. epilepsy, stroke, multiple sclerosis) 14. Contraindications to tDCS (including, but not limited to metal in the head or medical devices implanted in the brain, epilepsy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cortical arousal measured using resting state EEG activity pre and post stimulation during assessment nights | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sleepiness and subjective and objective arousal measured using Karolinska sleepiness scale, pre-sleep arousal scale and Psychomotor Vigilance Task pre and post stimulation during assessment nights 2. Sleep onset latency and sleep continuity measured using polysomnographic (PSG) sleep data recorded during assessment nights 3. Cortical arousal after the sleep period measured using resting state EEG activity after sleep period (both assessment nights) 4. Sleep-dependent cognition and daytime functioning measured using declarative memory task (overnight performance improvement) and daytime insomnia symptom scale (DISS) at pre- and post-assessment nights (memory task), after the sleep period (DISS), and at four timepoints during the day (after waking up, 12 am, 2 pm and 6 pm) | — |
Countries
United Kingdom
Outcome results
None listed