Novel Insomnia Treatment Experiment (NITE): The effectiveness of incorporating appropriate guidance for sleep wearable in users with insomnia
Monash UniversityDataset description
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.
Identifiers
Source Study
Trial name (public)
Novel Insomnia Treatment Experiment (NITE): The effectiveness of incorporating appropriate guidance for sleep wearable in users with insomniaTrial acronym
NITE
Trial ID
ACTRN12619001636145
Purpose
Treatment
Phase
Not Applicable
Funding
University,Monash University
Scientific enquiries
Ms Marie-Antoinette Spina
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 .... Read more
Key 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).
Key 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; .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 113
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Insomnia , Sleep Disturbance
Condition code Mental Health , Neurological
Intervention
Intervention code Behaviour , Diagnosis / Prognosis , Treatment: Devices
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 .... Read more
Comparison
Control group Active
The control intervention aims to provide participants with general information regarding sleep. Individuals will still receive two devices (Fitbit and Dreem) for objective sleep recording and will be required to complete daily self-reported sleep diary entries. However, they will not receive information about their recorded sleep. This active control is designed to control for nonspecific factors such as receiving sleep information and time with a researcher. The participants in this group will .... Read more
Outcomes
Outcome: The primary outcome measure is insomnia symptom severity measured via the Insomnia Severity Index total score (ISI; Bastien, Vallieres & Morin, 2001).Timepoint: It will be assessed at 2 timepoints: baseline (T1) and at the end of the study (T2). Primary time point will be T2.
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
All identifiable information will be destroyed and all de-identified data will be made publicly available after the final publication.
When will data be available?
The data will be made publicly available after the final publication with no end date.
Available to whom?
The de-identified database will be made available through Monash Figshare, a collaborative digital repository, to maximise the potential benefit to the scientific and research community. Access to Monash Figshare can be granted to anyone who contacts the project researchers.
Available for what types of analyses?
Research purposes.