Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000835448
Ethics application status
Approved
Date submitted
17/07/2025
Date registered
4/08/2025
Date last updated
4/08/2025
Date data sharing statement initially provided
4/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Sweat, Sleep, and Sobriety: Physical Activity and Sleep in Alcohol and Other Drugs Recovery
Scientific title
Impact of Physical Activity on Sleep in Adults Recovering from Substance Use Disorders: An Observational Study
Secondary ID [1] 314752 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance Use Disorders 337969 0
Condition category
Condition code
Mental Health 334284 334284 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This observational study uses an n-of-1 design to investigate the natural relationship between physical activity and sleep quality over 30 consecutive days. Participants represent three stages of substance use disorder (SUD) recovery: (1) individuals beginning residential treatment, (2) those transitioning into continuing care (after around six months of treatment), and (3) individuals in long-term (more than one year) recovery living in the community.

Participants will wear a thigh-mounted physical activity monitor (SENS Motion) throughout the study period. Sleep will be assessed using the same device and, for groups 2 and 3 (and optionally for group 1), also using an under-mattress sensor (Withings Sleep Analyzer) for 30 consecutive nights. The Withings Sleep Analyzer features a thermoplastic polyurethane pad filled with air and linked to a pressure sensor. It is placed under the mattress, beneath the participant’s torso, and detects pressure changes within the air bladder relative to atmospheric pressure. Data will be collected automatically and linked to an app on the study iPads (group 1) or participants’ mobile phones (groups 2 and 3).

In addition, participants will complete brief daily self-report surveys via ecological momentary assessment (EMA) once each evening for 30 days. The survey will be delivered through Qualtrics. Participants in group 1 will complete the surveys using study iPads distributed at the residential facility, while participants in groups 2 and 3 will receive survey links via SMS to their mobile phones each evening. These repeated measurements aim to track daily fluctuations and investigate how changes in physical activity may relate to sleep outcomes within and between individuals.
Intervention code [1] 331355 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341943 0
Physical activity
Timepoint [1] 341943 0
Daily for 30 consecutive days during the observation period
Primary outcome [2] 342291 0
Sleep quality
Timepoint [2] 342291 0
Daily for 30 consecutive days/nights during the observation period
Secondary outcome [1] 449107 0
Changes in positive affect
Timepoint [1] 449107 0
Daily for 30 consecutive days during the observation period
Secondary outcome [2] 449108 0
Changes in craving for substance use
Timepoint [2] 449108 0
Daily for 30 consecutive days during the observation period
Secondary outcome [3] 449109 0
Changes in well-being and recovery outcome assessed together as a composite outcome
Timepoint [3] 449109 0
Daily for 30 consecutive days during the observation period
Secondary outcome [4] 450258 0
Changes in negative affect
Timepoint [4] 450258 0
Daily for 30 consecutive days during the observation period

Eligibility
Key inclusion criteria
• Adults aged 18 years or older
• Current or previous experience with treatment for a substance use disorder (SUD)
• Adequate English proficiency to understand the study information, give informed consent, and independently complete study-related questionnaires and tasks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Diagnosis of a comorbid psychotic disorder (e.g., schizophrenia)
• Any condition that would interfere with participation in daily assessments or use of wearable devices
• A physical disability that limits their ability to engage in physical activity (i.e., a Global Physical Activity Questionnaire score of zero due to the condition).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
N-of-1 Study Analysis:
Descriptive statistics will summarise demographics, physical activity (PA), sleep, and substance use by group and overall. Each participant’s data will be analysed individually as a distinct time series. Missing data will be addressed via multiple imputation with bootstrapping using Amelia II in R, with imputations conducted separately per participant and variable. Results will be compared to complete-case analyses to assess robustness.
We will visualise daily trajectories of PA (e.g., step count, activity intensity), sleep (e.g., total sleep time, sleep efficiency), and psychological variables (e.g., mood, craving) to identify trends or anomalies.

Linear mixed models (LMMs) will examine within-person associations between PA and sleep, incorporating fixed effects for daily PA metrics, relevant covariates (e.g., prior night’s sleep, psychological states), random intercepts and slopes, and autocorrelation structures or lag terms. Model assumptions will be checked and addressed as needed using transformations or robust methods.

Time-lagged models will assess whether PA predicts sleep on the following night, adjusting for prior sleep and psychological states. Group-level comparisons will use interaction terms, and multilevel location-scale models within a dynamic structural equation modelling (DSEM) framework will explore predictors of both mean sleep and its variability.

All analyses will be conducted in Mplus, with a = 0.05 and 95% confidence intervals. Bayesian methods may be used if frequentist models cannot be estimated. Further details will be available in the published study protocol.

Validation Study Analysis:
We will assess agreement between the Withings Sleep Analyzer and the SENS Motion system for key sleep parameters, including total sleep time and sleep efficiency. Descriptive statistics will be reported for each device.

The primary analysis will involve intraclass correlation coefficients (ICCs) to quantify agreement for continuous metrics, interpreted using standard thresholds (e.g., greater than or equal to 0.75 = good, greater than or equal to 0.90 = excellent). Bland-Altman plots will illustrate mean differences and limits of agreement. Paired t-tests or non-parametric equivalents will test for significant differences in mean values between devices.

Data quality will be evaluated through distribution checks, missing data patterns, and outlier detection. Sensitivity analyses will exclude nights with incomplete or questionable data. All analyses will be conducted in R using the irr and BlandAltmanLeh packages. Further methodological detail will be provided in the published study protocol.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
1/05/2026
Actual
Date of last data collection
Anticipated
31/05/2026
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319303 0
University
Name [1] 319303 0
Curtin enAble Institute
Country [1] 319303 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Country
Australia
Secondary sponsor category [1] 322047 0
None
Name [1] 322047 0
Address [1] 322047 0
Country [1] 322047 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317881 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 317881 0
Ethics committee country [1] 317881 0
Australia
Date submitted for ethics approval [1] 317881 0
02/06/2025
Approval date [1] 317881 0
15/07/2025
Ethics approval number [1] 317881 0
HRE2025-0379

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142454 0
Mr Sascha Thal
Address 142454 0
Curtin enAble Institute, GPO Box U1987 Perth WA 6845
Country 142454 0
Australia
Phone 142454 0
+61 8 9266 4435
Fax 142454 0
Email 142454 0
[email protected]
Contact person for public queries
Name 142455 0
Sascha Thal
Address 142455 0
Curtin enAble Institute, GPO Box U1987 Perth WA 6845
Country 142455 0
Australia
Phone 142455 0
+61 8 9266 4435
Fax 142455 0
Email 142455 0
[email protected]
Contact person for scientific queries
Name 142456 0
Sascha Thal
Address 142456 0
Curtin enAble Institute, GPO Box U1987 Perth WA 6845
Country 142456 0
Australia
Phone 142456 0
+61 8 9266 4435
Fax 142456 0
Email 142456 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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
No additional documents have been identified.