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Trial registered on ANZCTR


Registration number
ACTRN12619001636145
Ethics application status
Approved
Date submitted
21/10/2019
Date registered
25/11/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Novel Insomnia Treatment Experiment (NITE): The effectiveness of incorporating appropriate guidance for sleep wearable in users with insomnia
Scientific title
Novel Insomnia Treatment Experiment (NITE): The effectiveness of incorporating appropriate guidance for sleep wearable in users with insomnia
Secondary ID [1] 299400 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
NITE
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Insomnia 314575 0
Sleep Disturbance 314576 0
Condition category
Condition code
Mental Health 312914 312914 0 0
Other mental health disorders
Neurological 313406 313406 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Feedback Intervention

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 whenever they wish during participation in the study.
• Feedback session (approximately 1 hour face-to-face): 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 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) and objective (Fitbit, Dreem) sleep information and will make comparisons between these two types of sleep information.
• Monthly check-in calls (approximately 10mins via telephone): participants will receive monthly check-in calls to assess compliance and answer questions. The first call will be conducted approximately one week after the feedback session.
• Cognitive Behavioural Therapy for Insomnia (CBT-I; face-to-face sessions of 1 hour): participants will receive CBT-I treatment delivered by psychologists. The duration of CBT-I treatment depends on individuals’ own progress and may be up to a few months. Key components of CBT-I include stimulus control, sleep restriction, cognitive therapy, relaxation, and sleep hygiene.

The design of this project is split into two phases: the first phase includes the components described (excluding CBT-I sessions), and the second phase includes everything described above. With both phases, the duration of the study could take up to three months of participation, depending on the number of sessions required. Not all participants will continue into the second phase of the study, as it will depend on their treatment preferences and suitability to CBT-I at that specific time. Suitability for phase two is that participants are willing to participate and attend session with a psychologist.

For participants who continue onto the second phase, the components described above (excluding the CBT-I sessions) will be delivered starting approximately three to four weeks before their commencement of the CBT-I sessions and will end at the conclusion of the sessions. This phase will occur immediately after phase 1 of the study, depending on the psychologist availability to start the sessions. There is no maximum or minimum number of sessions prescribed as they are conducted with a psychologist at a real-world clinic that specialises in insomnia. However, the decision about the number of sessions will be determined by the psychologist. Additionally, the format of the sessions, although often weekly or fortnightly, will vary depending on the participant’s and psychologist’s availability.

For participants who do not continue onto the second phase, the components described above (excluding the CBT-I sessions) will be delivered for a duration of approximately three to four weeks.
Intervention code [1] 315651 0
Diagnosis / Prognosis
Intervention code [2] 315652 0
Treatment: Devices
Intervention code [3] 315653 0
Behaviour
Comparator / control treatment
Brief Name: Sleep Education

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 receive the following components:
• Sleep education session (approximately 1 hour face-to-face) participants will receive a sleep education session that will cover: (1) sleep education, such as sleep stages and (2) sleep hygiene. This will be conducted with one of the research team members.
• Monthly check-in calls (approximately 10mins via telephone): participants will receive monthly check-in calls to assess compliance and answer questions. The first call will be conducted approximately one week after the sleep education session.
• Cognitive Behavioural Therapy for Insomnia (CBT-I; face-to-face sessions of 1 hour): participants will receive CBT-I treatment delivered by psychologists. The duration of CBT-I treatment depends on individuals’ own progress and may be up to a few months. Key components of CBT-I include stimulus control, sleep restriction, cognitive therapy, relaxation, and sleep hygiene.

The design of this project is split into two phases: the first phase includes the components described (excluding CBT-I sessions), and the second phase includes everything described above. The control intervention will be the same in both phases of the study.
Control group
Active

Outcomes
Primary outcome [1] 321515 0
The primary outcome measure is insomnia symptom severity measured via the Insomnia Severity Index total score (ISI; Bastien, Vallieres & Morin, 2001).
Timepoint [1] 321515 0
It will be assessed at 3 timepoints: baseline (T1), immediately before commencing routine CBT-I treatment (T2; about 4 weeks after baseline), and immediately after completing key components of CBT-I (T3). Primary time point will be T2.
Secondary outcome [1] 375196 0
Sleep quality measured using the PROMIS Sleep Disturbance short form (Buysse et al., 2012).
Timepoint [1] 375196 0
It will be assessed at 3 timepoints: baseline (T1), immediately before commencing routine CBT-I treatment (T2; about 4 weeks after baseline), and immediately after completing key components of CBT-I (T3).
Secondary outcome [2] 375197 0
Sleep-related impairment measured using the PROMIS Sleep-Related Impairment short form (Buysse et al., 2012).
Timepoint [2] 375197 0
It will be assessed at 3 timepoints: baseline (T1), immediately before commencing routine CBT-I treatment (T2; about 4 weeks after baseline), and immediately after completing key components of CBT-I (T3).
Secondary outcome [3] 375199 0
Anxiety symptomology measured using the PROMIS Emotional Distress Anxiety short form (Pilkonis et al. 2011).
Timepoint [3] 375199 0
It will be assessed at 3 timepoints: baseline (T1), immediately before commencing routine CBT-I treatment (T2; about 4 weeks after baseline), and immediately after completing key components of CBT-I (T3).
Secondary outcome [4] 375200 0
Depression symptomology measured using the PROMIS Emotional Distress Depression short form (Pilkonis et al. 2011).
Timepoint [4] 375200 0
It will be assessed at 3 timepoints: baseline (T1), immediately before commencing routine CBT-I treatment (T2; about 4 weeks after baseline), and immediately after completing key components of CBT-I (T3).
Secondary outcome [5] 375202 0
Fatigue measured using the Fatigue Severity Scale (Krupp et al., 1989).
Timepoint [5] 375202 0
It will be assessed at 3 timepoints: baseline (T1), immediately before commencing routine CBT-I treatment (T2; about 4 weeks after baseline), and immediately after completing key components of CBT-I (T3).
Secondary outcome [6] 375203 0
Sleep effort measured using the Glasgow Sleep Effort Scale (Broomfield & Espie, 2005).
Timepoint [6] 375203 0
It will be assessed at 3 timepoints: baseline (T1), immediately before commencing routine CBT-I treatment (T2; about 4 weeks after baseline), and immediately after completing key components of CBT-I (T3).
Secondary outcome [7] 375204 0
Quality of life measured using the Australian Quality of Life 4D (AQoL-4D; Richardson & Hawthorne, 1998).
Timepoint [7] 375204 0
It will be assessed at 3 timepoints: baseline (T1), immediately before commencing routine CBT-I treatment (T2; about 4 weeks after baseline), and immediately after completing key components of CBT-I (T3).
Secondary outcome [8] 375205 0
Pre-sleep arousal measured using the Pre-Sleep Arousal Scale (Nicassio, Mendlowitz, Fussell & Petras, 1985).
Timepoint [8] 375205 0
It will be assessed at 3 timepoints: baseline (T1), immediately before commencing routine CBT-I treatment (T2; about 4 weeks after baseline), and immediately after completing key components of CBT-I (T3).

Secondary outcome [9] 375206 0
Insomnia symptomology measured using the Duke Structured Interview for Sleep Disorders Insomnia Module (DSISD; Edinger et. al.. 2009).
Timepoint [9] 375206 0
It will be assessed at 3 timepoints: baseline (T1), immediately before commencing routine CBT-I treatment (T2; about 4 weeks after baseline), and immediately after completing key components of CBT-I (T3).

Eligibility
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).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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;
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.


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants will be randomized using a complete randomization scheme generated in advance. The randomization scheme will be generated and setup in REDCap by a member of the research staff who is (1) not involved in recruitment or delivery of intervention and (2) is not one of the study PIs. REDCap implements role-based security, which will be used to limit access based on user function to certain forms, reports and fields. To randomize a participant, an authorized research staff member will log in to REDCap, enter eligibility and stratification data on the participant and will receive the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. Block design with varying block sizes of 4, 6, and 8 will be used. Random seeds will be generated to assure allocation concealment and pre-guessing of the allocation sequence at the end of each block. Randomization will be stratified by baseline ISI (<15 and > 14).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention-to-treat basis. Missing data is expected in this study design as participation occurs over several weeks and will be addressed using multiple imputation or full information maximum likelihood. Data analysis will be conducted on a variety of programs including R and Mplus.

To examine group differences in primary and secondary outcomes at baseline (T1) and each subsequent time point (T2 and T3), multiple regression with treatment condition as predictor, controlling for relevant covariates will be used. In addition, effect sizes will be calculated to quantify size of group differences. To explore predictors of treatment response, potential predictors will be incorporated in regression analyses as predictor or moderators.

Assuming an attribution rate of 20%, randomising 90 participants in total (45 per group) will give the study 80% power (two tailed a = 0.05) to detect a medium effect size (d = 0.6). The effect size estimation is based on a previous behavioural intervention addressing discrepancy in subjective versus objective sleep information.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 28117 0
3168 - Notting Hill

Funding & Sponsors
Funding source category [1] 303907 0
University
Name [1] 303907 0
Monash University
Address [1] 303907 0
Wellington Road, Clayton, VIC 3168
Country [1] 303907 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road, Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 304055 0
None
Name [1] 304055 0
Address [1] 304055 0
Country [1] 304055 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304413 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 304413 0
Room 111, Chancellery Building E,
24 Sports Walk, Clayton Campus
Research Office
Monash University VIC 3800
Ethics committee country [1] 304413 0
Australia
Date submitted for ethics approval [1] 304413 0
30/07/2019
Approval date [1] 304413 0
06/08/2019
Ethics approval number [1] 304413 0
20856

Summary
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, (2) to explore potential mechanisms of change, and (3) to explore whether such monitoring and feedback improve the effectiveness of CBT-I (exploratory).
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 96866 0
Dr Bei Bei
Address 96866 0
School of Psychological Sciences Monash University
18 Innovation Walk, Clayton Campus
Clayton VIC 3800
Country 96866 0
Australia
Phone 96866 0
+61 3 9905 3903
Fax 96866 0
Email 96866 0
bei.bei@monash.edu
Contact person for public queries
Name 96867 0
Dr Bei Bei
Address 96867 0
School of Psychological Sciences Monash University
18 Innovation Walk, Clayton Campus
Clayton VIC 3800
Country 96867 0
Australia
Phone 96867 0
+61 3 9905 3903
Fax 96867 0
Email 96867 0
bei.bei@monash.edu
Contact person for scientific queries
Name 96868 0
Ms Marie-Antoinette Spina
Address 96868 0
School of Psychological Sciences Monash University
18 Innovation Walk, Clayton Campus
Clayton VIC 3800
Country 96868 0
Australia
Phone 96868 0
+61 3 9905 3903
Fax 96868 0
Email 96868 0
marie-antoinette.spina@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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 (start and end dates)?
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.
How or where can data be obtained?
Deidentified data will be accessible via Monash Figshare.
What supporting documents are/will be available?
No other documents available
Summary results
No Results