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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
9/12/2021
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
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.
Intervention code [1] 315651 0
Diagnosis / Prognosis
Intervention code [2] 315652 0
Treatment: Devices
Intervention code [3] 315653 0
Behaviour
Comparator / control treatment
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/ teleconference) 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.
• 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 sleep education 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.
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 2 timepoints: baseline (T1) and at the end of the study (T2). 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 2 timepoints: baseline (T1) and at the end of the study (T2). Primary time point will be T2.
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 2 timepoints: baseline (T1) and at the end of the study (T2). Primary time point will be T2.
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 2 timepoints: baseline (T1) and at the end of the study (T2). Primary time point will be T2.
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 2 timepoints: baseline (T1) and at the end of the study (T2). Primary time point will be T2.
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 2 timepoints: baseline (T1) and at the end of the study (T2). Primary time point will be T2.
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 2 timepoints: baseline (T1) and at the end of the study (T2). Primary time point will be T2.
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 2 timepoints: baseline (T1) and at the end of the study (T2). Primary time point will be T2.
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 2 timepoints: baseline (T1) and at the end of the study (T2). Primary time point will be T2.
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 2 timepoints: baseline (T1) and at the end of the study (T2). Primary time point will be T2.

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
Sex
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 at the end of the study (T2), 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
Completed
Date of first participant enrolment
Anticipated
9/12/2019
Actual
13/02/2020
Date of last participant enrolment
Anticipated
1/08/2021
Actual
8/10/2021
Date of last data collection
Anticipated
12/11/2021
Actual
13/11/2021
Sample size
Target
90
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303907 0
University
Name [1] 303907 0
Monash University
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
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
Trial website
Trial related presentations / publications
Public notes

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
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
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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDoes providing feedback and guidance on sleep perceptions using sleep wearables improve insomnia? Findings from "Novel Insomnia Treatment Experiment": a randomized controlled trial.2023https://dx.doi.org/10.1093/sleep/zsad167
Dimensions AIDoes changing perceptions of sleep by incorporating sleep wearables improve insomnia? Protocol for a randomized study (the Novel Insomnia Treatment Experiment)2023https://doi.org/10.1093/sleepadvances/zpad012
N.B. These documents automatically identified may not have been verified by the study sponsor.