Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial

Insomnia Clinical Trial

— SleepFix  

Official title:

Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06114901
• Other study ID #: X23-0371
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: October 26, 2028

Study information

• Verified date: October 2023
• Source: Woolcock Institute of Medical Research
• Contact: Matthew Rahimi, PhD
• Phone: 0061298053146
• Email: matthew.rahimi[@]mq.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The "SleepFix Study" is a clinical trial designed to evaluate the efficacy of mobile-delivered sleep restriction therapy (dBTi) in comparison to digital sleep health education (control) for treating insomnia disorder in adults aged 18 and above. The study is conducted entirely online, with 558 participants (279 in each group) and aims to determine the impact of the interventions on insomnia symptom severity, sleep metrics, subjective sleep quality, fatigue, anxiety, depressive symptoms, quality of life, medication usage, and workforce productivity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 558
• Est. completion date: October 26, 2028
• Est. primary completion date: October 26, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults aged = 18 years

• Able to give informed online consent

• Insomnia Severity Index = 12

• English fluency

• Access to a smartphone and willingness/proficiency to use a mobile application

Exclusion Criteria:

• Shift-workers (at least 2 night shifts a week between the hours of 8 pm to 8 am)

• Serious medical and/or psychiatric illnesses/disorders

• Previously diagnosed or suspected/high-risk of undiagnosed sleep disorders (e.g. REM Sleep Behaviour Disorder, Restless Leg Syndrome

• Currently receiving Cognitive Behavioural Therapy for insomnia (CBT-i)

• Operators of machinery that require high alertness (e.g. truck drivers, train drivers, pilots, etc)

• Pregnant women

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• SleepFix
SleepFix mobile application uses Sleep Retraining Therapy (SRT) which aims to reduce excess time spent in bed and reset sleep by matching time in bed (minimum of five and a half hours) to total sleep time (TST). There are four stages to the dBTi application and participants will progress based on completion of each stage. At the commencement of SleepFix application, participants enter sleep and bedtime data into the smartphone application for baseline referencing. These data are used to determine the sleep therapy based on a pre-determined algorithm that calculates optimum sleep efficiency.
• Sleep health Education modules
Three Sleep Health education modules that contain information about sleep hygiene and introduces strategies on how to reduce insomnia severity and increase sleep quality.

Locations

Country	Name	City	State
Australia	Woolcock Institute of Medical Research	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Woolcock Institute of Medical Research

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insomnia symptom severity change	Insomnia Severity Index (ISI) is a 7-item questionnaire used to examine overall insomnia severity. It consists of a five-point Likert type scale for each item (ranging from "no problem" = 0 to "severe problem" = 28) regarding symptoms over the past 2 weeks. Scores range from 0-28 with higher scores indicating greater insomnia symptom severity.	8 weeks
Secondary	Change in sleep-wake metrics	Sleep- wake metrics will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with seven component scores derived from the responses, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0-21) where a score of 5 or more indicates poor sleep quality.	8 weeks
Secondary	Daytime symptoms of fatigue	The Flinders Fatigue Scale (FFS) is a 7-item self-reported instrument designed to measure the level of subjective daytime fatigue experienced over the previous two weeks. 6-items consist of a 5-point Likert type scale ranging from "not at all" = 0 to "extremely" = 4. Item 5 uses a multiple-item checklist and is scored as a sum. All items are summed with total scores ranging from 0-31 with higher scores reflecting greater fatigue.	8 weeks
Secondary	Change in anxiety scores	The General Anxiety Disorder-7 (GAD-7) is a 7-item self-administered scale used to assess the severity of generalised anxiety over the previous 2 weeks. It consists of a three-point Likert type scale for each item (ranging from "not at all" = 0 to "nearly every day" = 3). All items are summed with total scores ranging from 0-21 where 5, 10 and 15 indicate the cut-off scores for mild, moderate and severe anxiety, respectively.	8 weeks
Secondary	Change in depressive symptom scores	The Patient Health Questionnaire-8 is an 8-item self-reported measure of depressive symptoms over the past 2 weeks. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score =3 for first 2 questions suggests anxiety. Total score =3 for last 2 questions suggests depression.	8 weeks
Secondary	Change in quality of life scores	The EuroQol five-dimensional (EQ-5D) is a self-reported questionnaire which assesses 5 dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression and overall health. The 5 dimensions range from "1 = indicating no problem" - "5 = indicating unable to/extreme problems" and the overall score from 0 (worst health state imaginable) to 100 (best health state imaginable).	8 weeks
Secondary	Treatment usability	The System Usability Scale (SUS) questionnaire is a 10-item survey that examines four dimensions of usability: useful- ness, ease of use, ease of learning, and satisfaction. It is scored out of a 100; scores closer to 100 means excellent usability while scores closer to 0 means worse usability.	8 weeks
Secondary	Workforce productivity	Participants will be asked short yes/no questions regarding the use of sleep medication in the previous two weeks.	8 Weeks
Secondary	Sleep medication usage	Participants will be asked short yes/no questions regarding taking sick leaves in the previous two weeks.	8 weeks