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SleepSLuMBERNCT02787577

The Sleep Lengthening and Metabolic Health, Body Composition, Energy Balance and Cardiovascular Risk Study

A study testing Sleep Lengthening in people with Sleep, run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Short sleep duration has been associated with increased risk of weight gain and development of non-communicable diseases. Sleep deprivation studies have suggested the link between restricted sleep and risk of adiposity and cardiometabolic dysregulation may be causal. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Sleep
What is being tested?
Sleep Lengthening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2016to Dec 2016
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 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male and female adults (18-64 years)
  • Habitually short sleepers (5-<7 hours of sleep per night on average on weekdays) - this is self-reported at screening, and confirmed by actigraphy when baseline measurement is taken.
  • BMI: 18.5 - <30

Who cannot join

  • Diagnosed medical conditions such as:
  • Cardiovascular disease
  • Type 1 or Type 2 Diabetes Mellitus
  • Cancer (excluding basal carcinoma) in the past five years
  • Chronic renal or liver disease
  • Inflammatory bowel disease
Show all 24Show fewer
  • Hypo/hyperthyroidism
  • Sleep conditions:
  • Chronic use of sleeping aid medication
  • Insomnia (Insomnia Severity Index - ISI Questionnaire)
  • Sleep apnoea (Berlin Questionnaire)
  • Extreme Chronotype (HorneOstberg questionnaire)
  • Pregnancy or lactation
  • Weight change of >3 kg in the previous two months
  • Previous or current high alcohol intake (>28 units/week for males and >21 units/week for females) or substance abuse
  • Smoking
  • Working hours outside 7 am - 7 pm
  • Habitual napping (>20 minutes per day on a regular basis)
  • Obliged to wake and care for family/friends (e.g. new born child etc)
  • Use of antidepressants
  • Depressed mood (Center of Epidemiologic Studies of Depression 20-item scale questionnaire)
  • Travel arrangements outside time zone within the periods of data collection
  • Travel arrangements outside time zone within period of intervention/control condition
  • Inability to adhere to a sleep hygiene intervention/sleep schedule due to time commitments

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Diabetes & Nutritional Sciences Division, King's College London

    London, SE1 9NH

Other trials in United Kingdom

About this study

Official title: The SLuMBER Study: The Sleep Lengthening and Metabolic Health, Body Composition, Energy Balance and Cardiovascular Risk Study

Short sleep duration has been associated with increased risk of weight gain and development of non-communicable diseases. Sleep deprivation studies have suggested the link between restricted sleep and risk of adiposity and cardiometabolic dysregulation may be causal. However, the severity and acuteness of sleep restriction schedules in laboratory-based studies could hinder the ecological validity of the findings. The pragmatic way forward is to assess how improved sleep in habitually short sleepers impacts the aforementioned outcomes. This study assesses the feasibility of lengthening sleep in short sleepers, as well as how improved sleep duration and/or quality impact metabolic health, body composition, energy balance and cardiovascular risk.

Read the detailed description

Research Questions

  • Is it feasible to improve sleep duration and quality in habitually short sleepers under free-living conditions?
  • What are the effects of improved sleep duration and quality on body composition, energy balance, dietary intake, and cardio-metabolic risk factors?

Hypothesis

  • Improved sleep duration and/or quality in habitually short sleepers will result in improved energy balance, diet quality, body composition, and cardio-metabolic risk profile.

Aims

  • To assess the feasibility of improving sleep duration and/or quality in habitually short sleepers using behavioural approaches and public health messages targeting sleep hygiene.
  • To identify how improved sleep duration and/or quality affect energy balance, diet quality, body composition, and cardio-metabolic risk profile.

Objectives

  1. To develop a sleep extension strategy using behaviour change techniques (BCTs) targeting sleep hygiene.
  2. To recruit healthy adults who are habitually short sleepers and randomise eligible participants to an intervention and control group.
  3. To assess the feasibility and effectiveness of the intervention.
  4. To measure energy balance, diet quality, body composition and cardio-metabolic risk factors pre- and post-treatment in the intervention and control groups.
  5. To assess whether the intervention had an effect on the aforementioned parameters by comparing the intervention endpoints to control as well as baseline measures.
  6. To run the statistical analysis both on an intention-to-treat basis as well as per-protocol.
Conditions
Sleep
Being tested
Sleep Lengthening
Keywords
Sleep Duration, Sleep Quality, Body Composition, Energy Intake, Energy Expenditure, Energy Balance, Cardiovascular Risk
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep LengtheningBehavioural

    Behaviour change techniques targeting sleep hygiene

Study groups in NCT02787577
Study groupRoleWhat they receive
Sleep LengtheningExperimentalThe intervention group will receive a personalised sleep consultation session to lengthen sleep by 1-1.5 hours per night by targeting sleep hygiene using behaviour change techniques for 4 weeks.
Receives: Behavioral: Sleep Lengthening
ControlNo interventionThe control group will be asked to resume their normal lifestyle.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep Duration

    Wrist Actigraphy

    Measured: baseline

  2. Sleep Duration

    Wrist Actigraphy

    Measured: week 4

  3. Sleep Quality

    Wrist Actigraphy

    Measured: baseline

  4. Sleep Quality

    Wrist Actigraphy

    Measured: week 4

Secondary outcomes (54)

  1. BMI

    Measured: baseline

  2. BMI

    Measured: day 28

  3. Body fat percentage

    Measured: baseline

  4. Body fat percentage

    Measured: day 28

  5. Blood pressure

    Measured: baseline

  6. Blood pressure

    Measured: day 28

  7. Fasting blood glucose

    Measured: baseline

  8. Fasting blood glucose

    Measured: day 28

  9. Fasting total cholesterol

    Measured: baseline

  10. Fasting HDL cholesterol

    Measured: baseline

  11. Fasting LDL cholesterol

    Measured: baseline

  12. Fasting triglycerides

    Measured: baseline

  13. Fasting total cholesterol

    Measured: day 28

  14. Fasting HDL cholesterol

    Measured: day 28

  15. Fasting LDL cholesterol

    Measured: day 28

  16. Fasting triglycerides

    Measured: day 28

  17. plasma leptin

    Measured: baseline

  18. plasma leptin

    Measured: day 28

  19. plasma ghrelin

    Measured: baseline

  20. plasma ghrelin

    Measured: day 28

  21. plasma insulin

    Measured: baseline

  22. plasma insulin

    Measured: day 28

  23. plasma cortisol

    Measured: baseline

  24. plasma cortisol

    Measured: day 28

  25. Homeostasis model assessment estimated insulin resistance (HOMA-IR)

    Measured: baseline

  26. Homeostasis model assessment estimated insulin resistance (HOMA-IR)

    Measured: day 28

  27. Waist circumference

    Measured: baseline

  28. Waist circumference

    Measured: day 28

  29. Hip circumference

    Measured: baseline

  30. Hip circumference

    Measured: day 28

  31. Lean body mass

    Measured: baseline

  32. Lean body mass

    Measured: day 28

  33. Digital volume pulse - Stiffness Index (SI)

    Measured: baseline

  34. Digital volume pulse - Stiffness Index (SI)

    Measured: day 28

  35. Digital volume pulse - Reflection Index (RI)

    Measured: baseline

  36. Digital volume pulse - Reflection Index (RI)

    Measured: day 28

  37. Mnemonic Similarity Test (MST)

    Measured: baseline

  38. Mnemonic Similarity Test (MST)

    Measured: day 28

  39. Dietary Intake (7-day food diary)

    Measured: baseline

  40. Dietary Intake (7-day food diary)

    Measured: week 4

  41. Resting Metabolic Rate (RMR)

    Measured: baseline

  42. Resting Metabolic Rate (RMR)

    Measured: day 28

  43. Total Energy Expenditure (TEE)

    Measured: baseline

  44. Total Energy Expenditure (TEE)

    Measured: day 21-23

  45. Urinary 6-sulphatoxymelatonin

    Analysed from spot urine sample

    Measured: baseline

  46. Urinary 6-sulphatoxymelatonin

    Analysed from spot urine sample

    Measured: day 28

  47. Recent Physical Activity Questionnaire (RPAQ)

    Measured: baseline

  48. Recent Physical Activity Questionnaire (RPAQ)

    Measured: day 28

  49. Sleep Hygiene Index (SHI)

    Measured: baseline

  50. Sleep Hygiene Index (SHI)

    Measured: day 28

  51. Eating Choices Index (ECI)

    Measured: baseline

  52. Eating Choices Index (ECI)

    Measured: day 28

  53. Pittsburgh Sleep Quality Index (PSQI)

    Measured: baseline

  54. Pittsburgh Sleep Quality Index (PSQI)

    Measured: day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02787577
Sponsor's protocol ID
SLuMBER Study 2016
Acronym
SLuMBER
Status last verified
Jun 2016
First submitted
5 Apr 2016
Last updated
17 Sep 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bosy-Westphal A, Hinrichs S, Jauch-Chara K, Hitze B, Later W, Wilms B, Settler U, Peters A, Kiosz D, Muller MJ. Influence of partial sleep deprivation on energy balance and insulin sensitivity in healthy women. Obes Facts. 2008;1(5):266-73. doi: 10.1159/000158874. Epub 2008 Oct 23.

    PubMed 20054188

  • Brondel L, Romer MA, Nougues PM, Touyarou P, Davenne D. Acute partial sleep deprivation increases food intake in healthy men. Am J Clin Nutr. 2010 Jun;91(6):1550-9. doi: 10.3945/ajcn.2009.28523. Epub 2010 Mar 31.

    PubMed 20357041

  • Buxton OM, Pavlova M, Reid EW, Wang W, Simonson DC, Adler GK. Sleep restriction for 1 week reduces insulin sensitivity in healthy men. Diabetes. 2010 Sep;59(9):2126-33. doi: 10.2337/db09-0699. Epub 2010 Jun 28.

    PubMed 20585000

  • Markwald RR, Melanson EL, Smith MR, Higgins J, Perreault L, Eckel RH, Wright KP Jr. Impact of insufficient sleep on total daily energy expenditure, food intake, and weight gain. Proc Natl Acad Sci U S A. 2013 Apr 2;110(14):5695-700. doi: 10.1073/pnas.1216951110. Epub 2013 Mar 11.

    PubMed 23479616

  • Shechter A, Rising R, Albu JB, St-Onge MP. Experimental sleep curtailment causes wake-dependent increases in 24-h energy expenditure as measured by whole-room indirect calorimetry. Am J Clin Nutr. 2013 Dec;98(6):1433-9. doi: 10.3945/ajcn.113.069427. Epub 2013 Oct 2.

    PubMed 24088722

  • Spiegel K, Leproult R, Van Cauter E. Impact of sleep debt on metabolic and endocrine function. Lancet. 1999 Oct 23;354(9188):1435-9. doi: 10.1016/S0140-6736(99)01376-8.

    PubMed 10543671

  • St-Onge MP, Roberts AL, Chen J, Kelleman M, O'Keeffe M, RoyChoudhury A, Jones PJ. Short sleep duration increases energy intakes but does not change energy expenditure in normal-weight individuals. Am J Clin Nutr. 2011 Aug;94(2):410-6. doi: 10.3945/ajcn.111.013904. Epub 2011 Jun 29.

    PubMed 21715510

  • St-Onge MP, O'Keeffe M, Roberts AL, RoyChoudhury A, Laferrere B. Short sleep duration, glucose dysregulation and hormonal regulation of appetite in men and women. Sleep. 2012 Nov 1;35(11):1503-10. doi: 10.5665/sleep.2198.

    PubMed 23115399

  • Al Khatib HK, Hall WL, Creedon A, Ooi E, Masri T, McGowan L, Harding SV, Darzi J, Pot GK. Sleep extension is a feasible lifestyle intervention in free-living adults who are habitually short sleepers: a potential strategy for decreasing intake of free sugars? A randomized controlled pilot study. Am J Clin Nutr. 2018 Jan 1;107(1):43-53. doi: 10.1093/ajcn/nqx030.

    PubMed 29381788

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Lengthening in people with Sleep, run by King's College London 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 3 inclusion and 24 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 17 Sep 2019. 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?

Sleep Duration (time frame: baseline). The study lists 4 primary outcomes in all. 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 NCT02787577, which also lists 9 linked publications.

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 17 Sep 2019.

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