None listed
Conditions
Brief summary
Insomnia constitutes a significant societal burden, and is thought to affect a significant portion of the adult population, with research citing between 5-20% of the population is affected by these symptoms. In particular, issues with falling asleep seem to be the most frequent complaint. Current treatments available for insomnia include medications such as benzodiazepines and antidepressants. However, long-term use of these has significant limitations, such as addiction, daytime carry-over effects, and a re-bound insomnia effect when medication use is suspended. Additional and/or alternative treatments include Cognitive Behaviour Therapy (CBT) or relaxation, where patients are taught to remedy symptoms through learning more adaptable coping skills. Although both treatment options are efficient, they can often be hard to access due to lack of access to scarce resources, time, motivation and the overall cost. When sleep architecture is clinically assessed, people typically undergo a sleep study. Patients are assessed using a number of physiological measures that indicate the time it takes them to get to sleep, how well they are able to maintain sleep, and whether they wake up during the night. Normally, as a person falls asleep, there are noticeable changes in these physiological measures, compared to when they are awake. In particular, when a person is drowsy and about to fall to sleep, slow eye blinks (slow eye closure) feature and these are thought to indicate the start of sleep. The current study is aiming to examine the use of volitional initiation of slow eye closure to see if attempts to manipulate the speed and time at which they occur might accelerate the start of sleep, coupled with self-distraction techniques, when compared to receiving information only about self-distraction alone. This intervention will be tested in insomnia patients over a period of approximately two weeks. First, participants will need to wear a sleep-activity monitoring watch for one week. This acti-watch will assess sleep and activity levels for a period of 7 days. After the one-week period of monitoring activity-sleep is complete, the participant will need to stay in the sleep laboratory at the Austin Hospital for one night. During the stay in the sleep laboratory, participants in the ‘treatment group’ will be instructed in a method of slow eye closure, using an electronic metronome to appropriately time eye closure, and will have a session with a trained sleep specialist about the use of self-distraction strategies. To test the effectiveness of this intervention, a control group will also be used. The control condition will involve taking part in a ‘self-distraction information only’ session. After the participant has learned either the combined self-distraction and eye closure technique or self-distraction-only technique in the laboratory, they will wear the watch for another week while practicing these strategies at home. After the week of wearing the sleep-monitoring watch, the researcher will collect the watch and also have the participant fill in few questionnaires, as well as a feedback sheet about their experience of the research. This feedback will assist in future, larger-scale version of this study and help to identify how the study may be improved.
Interventions
Combined VSEC and self-distraction: VSEC involves intentionally slowing eye closure to that which is seen in drowsy populations. For timing purposes, an electronic metronome will be used for the VSEC group during the one-night in-lab trials, and participants will be provided with one to take home for the POST-trial week. Metronomes are typically used in musical practice as a way of maintaining rhythm and tempo, and can be either electronic or mechanical. The metronome that will be used in the cu
Combined VSEC and self-distraction: VSEC involves intentionally slowing eye closure to that which is seen in drowsy populations. For timing purposes, an electronic metronome will be used for the VSEC group during the one-night in-lab trials, and participants will be provided with one to take home for the POST-trial week. Metronomes are typically used in musical practice as a way of maintaining rhythm and tempo, and can be either electronic or mechanical. The metronome that will be used in the current study is an electronic device that can be set to specific rates of beats-per minute and tone frequencies. For the current study, participants in the VSEC group will be exposed to a rate of 40 beats per minute. For each alternating beat, the participants will be required to close and open their eyes, resulting in a total objective measurement of 20 blinks per minute, under standardized instructions. The use of the 40 beats per minute (equal to 20 blinks per minute) for a period of 15 minutes in the experimental (VSEC) group will help promote slow-eye closure comparable to that which has been previously described. Participants will be taught this technique prior to bed-time on the in-lab study night. The self-distraction technique used in the 'active' group will be identical to that taught to he 'control' group, and will involve following the instruction of the researcher to think of pleasant thoughts or memories prior to bed time. During the POST week, participants will be required to complete a compliance log-book detailing that they have adhered to the study protocol (completing combined VSEC/self-distraction), and to ensure that they perform the technique they have been assigned, each night before bed.
Sponsors
Institute for Breathing and Sleep (IBAS)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Aged between 18-45 years. Capacity to give consent to the study and follow instructions and procedures Clinically significant (moderate-severe) (scores >15) indication of subjective insomnia symptoms as measured by the ISI. ESS score of <10
Exclusion criteria
Inability to speak or write English, or ESL. Diagnosed sleep disruptive medical condition (self-disclosure). MAPI score of > 0.5 Moderate-Severe depression (BDI) (cut off score > 20). Moderate- severe anxiety (BAI) (cut-off score >22) Currently pregnant. Currently employed in rotating or night-shift work. Sedative or stimulant medications use (self-disclosure). Illicit drug use (self-disclosure).
Outcome results
None listed