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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001268336
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
7/10/2026
Date registered
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22/10/2026
Date last updated
Help: Date last updated
22/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
22/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Can a temperature-controlled mattress topper improve sleep after spinal cord injury?
Scientific title
Sleep-SCIence: Temperature-Controlled Mattress Toppers for Sleep Management in Adults with Spinal Cord Injury
Additional trial identifiers [1] 318161 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Spinal cord injury 343214 0
Sleep disturbance 343215 0
Condition category
Condition code
Neurological 339303 339303 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants will use a commercially available temperature-controlled mattress topper (Eight Sleep Pod) during sleep for a 21-night intervention condition. The temperature-controlled mattress cover controls temperature by continuously regulating water temperature flowing through the mattress cover to each individual’s preference while they sleep. The Pod consists of a hub that sits beside the bed and is connected to two embedded water tubes for active cooling and heating, which connect to a cover that fits over the mattress like a thick fitted sheet. Users can create a temperature profile on the smartphone application over three stages of the night. During the mattress topper condition, participants will be given an initial familiarisation period of approximately 3 nights to become familiar with the mattress topper and adjust the temperature settings to their preferred comfort range. Participants will be able to adjust the temperature settings according to their own comfort and preference. Although the device permits settings across the full -10 to +10 range (approximately 13–43 °C circulating water temperature), participants in this study will be restricted to settings between -5 and +5 (approximately 20–36 °C). Settings will be configured within this range by the research team during setup, participants will be instructed to remain within it, and adherence will be verified from device application data at weekly contact. The mattress cover also contains an AI-driven Autopilot feature designed to automatically adjust bed temperature during a sleep episode via multiple data streams (e.g., user sleep stage estimates, heart rate/heart rate variability, sleep/wake timing, room temperature and humidity, respiratory rate, and presence). The Autopilot feature may operate, but only within the restricted range. Accordingly, the temperature may vary throughout the night depending on these factors and the participant's selected temperature settings. Participants will complete a 21-night usual-sleep condition and a 21-night intervention condition using the temperature-controlled mattress topper, separated by a three-night washout during which the topper is switched off and the cover removed. Total participation is 45 nights.
Intervention code [1] 335056 0
Treatment: Devices
Description of the comparator or control
Usual sleep condition: Participants will complete a 21-night control period under their normal sleep conditions and will be asked to maintain their usual sleep routine. Sleep will be monitored using the Ultrahuman Ring AIR throughout this period. In this crossover design, each participant will act as their own control.
Control group
Active

Outcomes
Primary outcome [1] 346533 0
Total sleep time
Timepoint [1] 346533 0
Collected nightly throughout each 21-night study condition.
Primary outcome [2] 347171 0
Sleep efficiency
Timepoint [2] 347171 0
Collected nightly throughout each 21-night study condition.
Primary outcome [3] 347172 0
Number of nocturnal awakenings
Timepoint [3] 347172 0
Collected nightly throughout each 21-night study condition.
Secondary outcome [1] 466265 0
Sleep quality
Timepoint [1] 466265 0
At the end of each 21-night study condition
Secondary outcome [2] 466266 0
Insomnia symptoms
Timepoint [2] 466266 0
At the end of each 21-night study condition.
Secondary outcome [3] 466267 0
Depression symptoms
Timepoint [3] 466267 0
At the end of each 21-night study condition.
Secondary outcome [4] 466268 0
Psychological wellbeing
Timepoint [4] 466268 0
At the end of each 21-night study condition.
Secondary outcome [5] 466269 0
Continuous skin temperature
Timepoint [5] 466269 0
During one matched night in each 21-night study condition, for two nights in total. The measurement nights will be selected by the research team in consultation with participants, aiming to assess skin temperature on the same relative night of each condition.
Secondary outcome [6] 466270 0
Perceived thermal comfort
Timepoint [6] 466270 0
Every morning during both 21-night study conditions.
Secondary outcome [7] 469257 0
Primary outcome: Wake after sleep onset (WASO)
Timepoint [7] 469257 0
Collected nightly throughout each 21-night study condition.
Secondary outcome [8] 469258 0
Anxiety symptoms
Timepoint [8] 469258 0
At the end of each 21-night study condition.
Secondary outcome [9] 469259 0
Stress symptoms
Timepoint [9] 469259 0
At the end of each 21-night study condition.

Eligibility
Key inclusion criteria
Participants must: (i) be aged 18–65 years; (ii) have a traumatic or non-traumatic spinal cord injury with a neurological level between C1 and L2, sustained at least 1 year previously; (iii) be able to provide informed consent; (iv) be able to understand written and spoken English sufficiently to complete the consent process, communicate with the research team, and complete study questionnaires; (v) sleep in a standard domestic bed that can accommodate the mattress cover, with mains power and home Wi-Fi available; (vi) be able to operate the Eight Sleep and Ultrahuman smartphone applications independently, or have a partner, carer or support person routinely available overnight who is able to do so on their behalf; and (vii) be on stable doses of any medications known to affect sleep or thermoregulation (for example baclofen, gabapentinoids, opioids, anticholinergics, antidepressants) for at least 4 weeks prior to enrolment, with no dose change planned during the study period.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Individuals will be excluded if they: (i) have a current stage 2 or higher pressure injury at any site in contact with the bed surface, or a stage 3 or 4 pressure injury at a bed-contact site within the previous 6 months; (ii) use an alternating-pressure, low-air-loss or other prescribed pressure-redistribution mattress or overlay, or sleep in a profiling or hospital bed to which the mattress cover cannot be safely and fully fitted; (iii) have a diagnosed circadian rhythm sleep–wake disorder or narcolepsy; (iv) have obstructive sleep apnoea for which treatment has been initiated or altered within the previous month, or for which a change is planned during the study period; (v) are pregnant or planning pregnancy during the study period; or (vi) have a hand or finger condition that prevents comfortable and reliable wear of the smart ring, such as significant oedema, contracture, severe spasticity, open wounds, or markedly impaired peripheral perfusion.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation schedule will assign participants to one of two condition orders: usual sleep followed by mattress topper, or mattress topper followed by usual sleep. Condition order will be counterbalanced across participants.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Based on our published data in healthy adults (Stevenson et al., 2025), which demonstrated a large effect size (d = 0.92) for perceived sleep quality with the temperature-controlled mattress topper, a priori power analysis (G*Power 3.1; (Faul et al., 2007)) indicates that 13 participants are required to detect a comparable effect with >80% power (a = 0.05, two-tailed paired t-test). To account for a conservatively smaller effect in a clinical population, potential attrition, and incomplete data (e.g., non-compliance with device use), we will recruit 20 participants, providing >80% power to detect a moderate-to-large effect (d = 0.67). This sample size is consistent with similar feasibility and proof-of-concept studies in clinical sleep populations. As the first study to evaluate this intervention in individuals with SCI, the primary purpose is to establish feasibility, acceptability, and preliminary efficacy, with findings intended to inform the design and power calculations for a subsequent larger-scale trial.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2026
Actual
Date of last participant enrolment
Anticipated
30/09/2027
Actual
Date of last data collection
Anticipated
30/11/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322724 0
Charities/Societies/Foundations
Name [1] 322724 0
Marigold Southey & Freemasons Foundation Victoria SCI Research Grant
Country [1] 322724 0
Australia
Funding source category [2] 322739 0
University
Name [2] 322739 0
La Trobe University
Country [2] 322739 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 325646 0
None
Name [1] 325646 0
Address [1] 325646 0
Country [1] 325646 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321166 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 321166 0
Ethics committee country [1] 321166 0
Australia
Date submitted for ethics approval [1] 321166 0
05/08/2026
Approval date [1] 321166 0
24/09/2026
Ethics approval number [1] 321166 0
HEC26377

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

Contacts
Principal investigator
Name 152882 0
Prof Matthew Driller
Address 152882 0
La Trobe University, La Trobe Sports Stadium, Kingsbury Drive, Bundoora VIC 3086
Country 152882 0
Australia
Phone 152882 0
+61404014647
Fax 152882 0
Email 152882 0
[email protected]
Contact person for public queries
Name 152883 0
Matthew Driller
Address 152883 0
La Trobe University, La Trobe Sports Stadium, Kingsbury Drive, Bundoora VIC 3086
Country 152883 0
Australia
Phone 152883 0
+61404014647
Fax 152883 0
Email 152883 0
[email protected]
Contact person for scientific queries
Name 152884 0
Matthew Driller
Address 152884 0
La Trobe University, La Trobe Sports Stadium, Kingsbury Drive, Bundoora VIC 3086
Country 152884 0
Australia
Phone 152884 0
+61404014647
Fax 152884 0
Email 152884 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data will not be shared because participants consented to their data being used only for the approved purposes of this study, and no future secondary use or external sharing is planned.



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.