Short SleepNCT04467268
Sleep Extension for Metabolic Health
A study testing Sleep extension in people with Short Sleep, run by Loughborough University at 1 site in United Kingdom.
Trial summary
The study aims to examine the effects of a sleep extension intervention on the metabolic and cardio-vascular profile of obese people who present traditional diabetes risk factors, and who are habitually sleep deprived. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Short Sleep
- What is being tested?
- Sleep extension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2017to 15 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 25 to 55 years (inclusive)
- Gender: Men
- BMI > 25kg/m2
- Average self-reported sleep duration of ≤ 6h per 24h
- Stable daily sleep/wake schedule
- Health risk screening score ≥ 2
Who cannot join
- Diagnosed sleep disorder as per DSM-5: e.g. insomnia, restless legs syndrome, moderate/severe Obstructive Sleep Apnoea; Epworth Sleepiness Score: <5
- Diagnosed chronic conditions, or medication, likely to interfere with regular sleep: T2D, chronic fatigue syndrome, fibromyalgia, COPD, uncontrolled depression/anxiety, other severe psychiatric illness, substance abuse.
- Night/evening shift work , regular time-zone travel, other circumstances preventing regular sleep schedule (e.g. very young children, carer at night for sick relatives etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Extension in Overweight Short Sleepers: A Randomised Controlled Trial:
The study aims to examine the effects of a sleep extension intervention on the metabolic and cardio-vascular profile of obese people who present traditional diabetes risk factors, and who are habitually sleep deprived. Participants randomized to the intervention arm will complete a 6-week sleep extension intervention, whilst the control group will maintain their habitual sleep schedule. It is hypothesized that the sleep extension intervention will significantly increase total sleep time, and will be accompanied by significant metabolic-related changes.
Read the detailed description
Recent epidemiological (survey) research, conducted in both in healthy populations and among those with existing chronic disease, shows that insufficient sleep can significantly contribute to ill health (including diabetes, heart disease and obesity). These findings have also been accompanied by credible explanatory mechanisms emphasising the role of sleep in regulating appetite, satiety, glucose and daytime stamina. Sleep extension, therefore, is a largely unexplored pathway for improving individual health, and reducing an existing risk of diabetes. If successful, increased sleep duration and quality could be adopted as an achievable public health intervention.
The study aims to recruit a total of 20 men, overweight, presenting traditional risks of developing diabetes, who are habitually short sleepers. Participants are then randomized, stratified by weight status, to a sleep extension group, or a control sleep monitoring group. Baseline measures include sleep actigraphy, continuous glucose monitoring, blood pressure, and a mixed-meal tolerance test; after the 6-week intervention, the same measures are repeated.
- Conditions
- Short Sleep
- Being tested
- Sleep extension
- Keywords
- short sleep, insufficient sleep, sleep extension, diabetes risk
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep extensionBehavioural
The sleep extension programme was designed around four alternative assumptions: 1) that among this group of habitual short sleepers, extending time in bed (TIB) would represent a significant behavioral change to established night-time and daytime routines; 2) that for practical purposes (accommodating personal, family and work schedules) extended time in bed is best anchored against typical rise-times; 3) that sleep onset may represent a particular challenge for those advancing habitual bed-times by over 1 hour each night; and 4) that in consenting to the trial, participants were motivated to make and sustain behavioral change.
| Study group | Role | What they receive |
|---|---|---|
| Sleep extension intervention | Experimental | Intervention group participants met with an experienced sleep scientist to discuss and agree changes to their sleep and personal schedules. Discussions lasted 60-90 minutes, were informed by actigraphic sleep assessments from the baseline period, and aimed to increase TST by ≥1 hour/night. The structure and content of the "About Sleep", "Sleep Hygiene" and "Thoughts and Sleep" components of the online Sleepful application, a self-help sleep management programme. Advice was supported by the provision of self-help booklets addressing sleep hygiene and the management of pre-sleep cognitions which had been successfully trailed in an intervention for insomnia symptoms. Finally, to capitalize on the participant's motivation at recruitment, and optimize adherence, the newly agreed sleep schedule was written into an agreement which the participant was asked to sign, simulating a 'therapeutic contract'. Schedules were reviewed by telephone at the end of the first week and revised if required. Receives: Behavioral: Sleep extension |
| Control group | No intervention | Participants in the control group were asked to continue with their habitual sleep schedule. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time (TST)
Time asleep obtained every night, as measured by actigraphy (minutes).
Measured: 24 hours
Secondary outcomes (14)
Time in Bed (TIB)
Time between getting into and getting out of bed (minutes)
Measured: 24 hours
Sleep onset latency (SOL)
Time to fall asleep (minutes)
Measured: 24 hours
Wake after sleep onset (WASO)
Time awake after the first sleep period (minutes)
Measured: 24 hours
Glucose concentration
Total area under the glucose concentration curve
Measured: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
Insulin concentration
Total area under the insulin concentration curve
Measured: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
Total PYY concentration
Total area under the PYY concentration curve
Measured: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
Grelin concentration
Total area under the ghrelin concentration curve
Measured: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
Leptin concentration
Fasting leptin levels
Measured: 8-hour fasting blood samples
Minutes per 24 hours of Moderate to vigorous physical activity (MVPA)
Physical activity recorded with actigraphs
Measured: 24 hours
Standard Deviation of Blood Glucose Standard Deviation of Blood Glucose
Obtained from all CGMs 24-hour blood glucose concentrations across the monitoring period with
Measured: 14 days
Mean Amplitude of Glycemic Excursions
Mean blood glucose values exceeding one standard deviation of the 24-hour arithmetic average across the monitoring period
Measured: 24 hours
Systolic and diastolic blood pressure
Measurements of arterial blood pressure were taken, each after resting in a supine position for 10 minutes in a fasting state
Measured: 10 minutes
Pittsburgh Sleep Quality Index
Self-reported measure of sleep quality, score range 0-21,higher scores indicate worse sleep quality.
Measured: One month
Multidimensional Assessment of Fatigue
Self-reported assessment of experienced fatigue, scores range from 1 to 50, higher scores indicate worse fatigue.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start15 Apr 2017
- Primary completion15 Apr 2018
- Study completion15 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Short SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester, University of Leicester
- Responsible party
- Principal investigator, Dr Iuliana Hartescu, Loughborough University
- Investigators
- Iuliana Hartescu, PhD, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467268
- Sponsor's protocol ID
- LBO-SSEHS-SE_IH
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hartescu I, Stensel DJ, Thackray AE, King JA, Dorling JL, Rogers EN, Hall AP, Brady EM, Davies MJ, Yates T, Morgan K. Sleep extension and metabolic health in male overweight/obese short sleepers: A randomised controlled trial. J Sleep Res. 2022 Apr;31(2):e13469. doi: 10.1111/jsr.13469. Epub 2021 Aug 29.
PubMed 34459060
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Extension in Overweight Short Sleepers: A Randomised Controlled Trial:
- ClinicalTrials.gov ID
- NCT04467268
- Acronym / sponsor ID
- LBO-SSEHS-SE_IH
- Conditions
- Short Sleep
- Keywords
- short sleep, insufficient sleep, sleep extension, diabetes risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester, University of Leicester
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 15 Apr 2018 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to examine the effects of a sleep extension intervention on the metabolic and cardio-vascular profile of obese people who present traditional diabetes risk factors, and who are habitually sleep deprived. Participants randomized to the intervention arm will complete a 6-week sleep extension intervention, whilst the control group will maintain their habitual sleep schedule. It is hypothesized that the sleep extension intervention will significantly increase total sleep time, and will be accompanied by significant metabolic-related changes.
Detailed description
Recent epidemiological (survey) research, conducted in both in healthy populations and among those with existing chronic disease, shows that insufficient sleep can significantly contribute to ill health (including diabetes, heart disease and obesity). These findings have also been accompanied by credible explanatory mechanisms emphasising the role of sleep in regulating appetite, satiety, glucose and daytime stamina. Sleep extension, therefore, is a largely unexplored pathway for improving individual health, and reducing an existing risk of diabetes. If successful, increased sleep duration and quality could be adopted as an achievable public health intervention.
The study aims to recruit a total of 20 men, overweight, presenting traditional risks of developing diabetes, who are habitually short sleepers. Participants are then randomized, stratified by weight status, to a sleep extension group, or a control sleep monitoring group. Baseline measures include sleep actigraphy, continuous glucose monitoring, blood pressure, and a mixed-meal tolerance test; after the 6-week intervention, the same measures are repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Sleep extension intervention | Experimental | Behavioral: Sleep extensionIntervention group participants met with an experienced sleep scientist to discuss and agree changes to their sleep and personal schedules. Discussions lasted 60-90 minutes, were informed by actigraphic sleep assessments from the baseline period, and aimed to increase TST by ≥1 hour/night. The structure and content of the "About Sleep", "Sleep Hygiene" and "Thoughts and Sleep" components of the online Sleepful application, a self-help sleep management programme. Advice was supported by the provision of self-help booklets addressing sleep hygiene and the management of pre-sleep cognitions which had been successfully trailed in an intervention for insomnia symptoms. Finally, to capitalize on the participant's motivation at recruitment, and optimize adherence, the newly agreed sleep schedule was written into an agreement which the participant was asked to sign, simulating a 'therapeutic contract'. Schedules were reviewed by telephone at the end of the first week and revised if required. |
| Control group | No intervention | –Participants in the control group were asked to continue with their habitual sleep schedule. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 25 to 55 years (inclusive)
- Gender: Men
- BMI > 25kg/m2
- Average self-reported sleep duration of ≤ 6h per 24h
- Stable daily sleep/wake schedule
Key exclusion criteria (3 listed)
- Diagnosed sleep disorder as per DSM-5: e.g. insomnia, restless legs syndrome, moderate/severe Obstructive Sleep Apnoea; Epworth Sleepiness Score: <5
- Diagnosed chronic conditions, or medication, likely to interfere with regular sleep: T2D, chronic fatigue syndrome, fibromyalgia, COPD, uncontrolled depression/anxiety, other severe psychiatric illness, substance abuse.
- Night/evening shift work , regular time-zone travel, other circumstances preventing regular sleep schedule (e.g. very young children, carer at night for sick relatives etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep extensionThe sleep extension programme was designed around four alternative assumptions: 1) that among this group of habitual short sleepers, extending time in bed (TIB) would represent a significant behavioral change to established night-time and daytime routines; 2) that for practical purposes (accommodating personal, family and work schedules) extended time in bed is best anchored against typical rise-times; 3) that sleep onset may represent a particular challenge for those advancing habitual bed-times by over 1 hour each night; and 4) that in consenting to the trial, participants were motivated to make and sustain behavioral change. | Behavioural | Sleep extension intervention |
Primary outcome
Total sleep time (TST)
Time frame: 24 hours
Time asleep obtained every night, as measured by actigraphy (minutes).
14 secondary outcomes
Time in Bed (TIB)
Time frame: 24 hours
Sleep onset latency (SOL)
Time frame: 24 hours
Wake after sleep onset (WASO)
Time frame: 24 hours
Glucose concentration
Time frame: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
Insulin concentration
Time frame: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
Total PYY concentration
Time frame: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
Grelin concentration
Time frame: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
Leptin concentration
Time frame: 8-hour fasting blood samples
Minutes per 24 hours of Moderate to vigorous physical activity (MVPA)
Time frame: 24 hours
Standard Deviation of Blood Glucose Standard Deviation of Blood Glucose
Time frame: 14 days
Mean Amplitude of Glycemic Excursions
Time frame: 24 hours
Systolic and diastolic blood pressure
Time frame: 10 minutes
Pittsburgh Sleep Quality Index
Time frame: One month
Multidimensional Assessment of Fatigue
Time frame: One week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Derived from this study: PubMed 34459060Hartescu I, Stensel DJ, Thackray AE, King JA, Dorling JL, Rogers EN, Hall AP, Brady EM, Davies MJ, Yates T, Morgan K. Sleep extension and metabolic health in male overweight/obese short sleepers: A randomised controlled trial. J Sleep Res. 2022 Apr;31(2):e13469. doi: 10.1111/jsr.13469. Epub 2021 Aug 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iuliana Hartescu, PhD principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep extension in people with Short Sleep, run by Loughborough University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep time (TST) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04467268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.