Assessing the effects of brain stimulation on sleep in people with insomnia
- Conditions
- InsomniaMental and Behavioural DisordersNonorganic insomnia
- Registration Number
- ISRCTN61956079
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 40
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method