None listed
Conditions
Brief summary
The diagnosis of insomnia is made based on an individual’s self-reported sleep complaints. Research has found varying degrees of discrepancy between self-reported and objectively measured sleep. Individuals with insomnia tend to overestimate the time they spent awake during the night and how long it took them to fall asleep compared to normal sleepers. They also tend to underestimate their total sleep time compared to normal sleepers. Further, greater discrepancy has been associated with higher insomnia severity, and Cognitive Behavioural Therapy for Insomnia (CBT-I), an effective non-pharmacological intervention for insomnia, has been shown to reduce this discrepancy. Sleep-measuring wearables are increasingly used by consumers. However, the existing devices rarely provide feedback with guidance to support helpful interpretation of objectively recorded sleep. This is especially important for individuals with insomnia, where appropriate guidance on interpreting objective-perceived sleep discrepancy may be large. Conversely, CBT-I was developed before the rise of consumer wearables and does not typically incorporate data from these devices despite them being available from many patients. Therefore, the aims of this study are threefold (1) to examine whether providing monitoring and feedback on objective sleep with support for helpful interpretation of discrepancy improves insomnia and (2) to explore potential mechanisms of change.
Interventions
The feedback intervention aims to provide participants with information about objectively recorded sleep (Fitbit and Dreem devices) and guidance regarding how to interpret this information throughout the study. Individuals will be given two devices (Fitbit and Dreem) for objective sleep recording and will be required to complete daily self-reported sleep diary entries.
The participants in this group will receive the following components:
• Daily objective sleep information: participants will b
The feedback intervention aims to provide participants with information about objectively recorded sleep (Fitbit and Dreem devices) and guidance regarding how to interpret this information throughout the study. Individuals will be given two devices (Fitbit and Dreem) for objective sleep recording and will be required to complete daily self-reported sleep diary entries. The participants in this group will receive the following components: • Daily objective sleep information: participants will be able to access their daily sleep information from the Fitbit app after their feedback session (see below). • Feedback session (approximately 1 hour face-to-face/ teleconference): participants will receive a feedback and coaching session that will cover: (1) the differences between self-report and objective sleep, (2) the nature of discrepancy and its relevance to insomnia, and (3) healthy interpretation of discrepancy using cognitive behavioural therapy for insomnia (CBT-I) principles. This will be conducted with one of the research team members and will occur approx. one week after the equipment is given to participants, so there is at least one week of baseline data. • Weekly sleep report (approximately 1min via email): participants will receive weekly reports that give an overview of how their sleep has been over the week. This report will include both subjective (sleep diary), objective (Fitbit, Dreem) sleep information and will make comparisons between these two types of sleep information. • Two check-in calls (approximately 10mins via telephone): participants will receive check-in calls to assess compliance and answer questions. The first call will be conducted approximately one week after the feedback session, the second call will be conducted within the last week of the five-week participation. This study is completed over a five-week period. It will include all the components described above and a typical day of participation (without any sessions or questionnaires) will require an approximate commitment of 10 minutes.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(a) 18 years old or above; (b) Able to communicate in English; (c) Have regular access to internet, smartphone and email; (d) Experiencing insomnia symptoms (Insomnia Severity Index of 10 or above).
Exclusion criteria
(a) Participants who endorse symptoms of, or are known to have any of the following sleep disorders as determined by the DUKE Structured Interview for Sleep Disorders (DSISD): o Sleep apnea: loud snoring, or observed gasping or pauses in breathing, or previously diagnosed with apnea hypopnea index > 15 but not/inadequately treated; o Previously diagnosed Periodic Limb Movement Disorder with arousal index > 15; o Restless Legs Syndrome occurring 3 times/week, with duration of at least one month; o Circadian Rhythm Sleep-Wake Disorders. These include irregular and non-24-hour sleep-wake types, advanced (if habitual bedtime is earlier than 8pm and habitual wake time earlier than 4am, occasional deviation allowed) and delayed (if habitual bedtime later than 3am and habitual wake time later than 11am, occasional deviation allowed) sleep phase types; (b) Participants with current fixed night shift work between midnight and 5am, or current rotating work schedules that require night shifts during the study period. (c) Participants who are at risk determined by individuals who select either moderate or high on the suicidal ideation item on the baseline questionnaire. (d) Participants who have used Fitbit in the month prior to participation.
Outcome results
None listed