Skip to main content
OpenTrials
Completed

NCT Number: NCT02787577

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes & Nutritional Sciences Division, King's College London

London, SE1 9NH, United Kingdom

About this study

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

  • To develop a sleep extension strategy using behaviour change techniques (BCTs) targeting sleep hygiene.
  • To recruit healthy adults who are habitually short sleepers and randomise eligible participants to an intervention and control group.
  • To assess the feasibility and effectiveness of the intervention.
  • To measure energy balance, diet quality, body composition and cardio-metabolic risk factors pre- and post-treatment in the intervention and control groups.
  • To assess whether the intervention had an effect on the aforementioned parameters by comparing the intervention endpoints to control as well as baseline measures.
  • To run the statistical analysis both on an intention-to-treat basis as well as per-protocol.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Sleep Lengthening

Behavioral

Behaviour change techniques targeting sleep hygiene

Primary outcomes

  1. Sleep Duration

    Time frame: baseline

    Wrist Actigraphy

  2. Sleep Duration

    Time frame: week 4

    Wrist Actigraphy

  3. Sleep Quality

    Time frame: baseline

    Wrist Actigraphy

  4. Sleep Quality

    Time frame: week 4

    Wrist Actigraphy

Secondary outcomes

  1. BMI

    Time frame: baseline

  2. BMI

    Time frame: day 28

  3. Body fat percentage

    Time frame: baseline

  4. Body fat percentage

    Time frame: day 28

  5. Blood pressure

    Time frame: baseline

  6. Blood pressure

    Time frame: day 28

  7. Fasting blood glucose

    Time frame: baseline

  8. Fasting blood glucose

    Time frame: day 28

  9. Fasting total cholesterol

    Time frame: baseline

  10. Fasting HDL cholesterol

    Time frame: baseline

  11. Fasting LDL cholesterol

    Time frame: baseline

  12. Fasting triglycerides

    Time frame: baseline

  13. Fasting total cholesterol

    Time frame: day 28

  14. Fasting HDL cholesterol

    Time frame: day 28

  15. Fasting LDL cholesterol

    Time frame: day 28

  16. Fasting triglycerides

    Time frame: day 28

  17. plasma leptin

    Time frame: baseline

  18. plasma leptin

    Time frame: day 28

  19. plasma ghrelin

    Time frame: baseline

  20. plasma ghrelin

    Time frame: day 28

  21. plasma insulin

    Time frame: baseline

  22. plasma insulin

    Time frame: day 28

  23. plasma cortisol

    Time frame: baseline

  24. plasma cortisol

    Time frame: day 28

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

    Time frame: baseline

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

    Time frame: day 28

  27. Waist circumference

    Time frame: baseline

  28. Waist circumference

    Time frame: day 28

  29. Hip circumference

    Time frame: baseline

  30. Hip circumference

    Time frame: day 28

  31. Lean body mass

    Time frame: baseline

  32. Lean body mass

    Time frame: day 28

  33. Digital volume pulse - Stiffness Index (SI)

    Time frame: baseline

  34. Digital volume pulse - Stiffness Index (SI)

    Time frame: day 28

  35. Digital volume pulse - Reflection Index (RI)

    Time frame: baseline

  36. Digital volume pulse - Reflection Index (RI)

    Time frame: day 28

  37. Mnemonic Similarity Test (MST)

    Time frame: baseline

  38. Mnemonic Similarity Test (MST)

    Time frame: day 28

  39. Dietary Intake (7-day food diary)

    Time frame: baseline

  40. Dietary Intake (7-day food diary)

    Time frame: week 4

  41. Resting Metabolic Rate (RMR)

    Time frame: baseline

  42. Resting Metabolic Rate (RMR)

    Time frame: day 28

  43. Total Energy Expenditure (TEE)

    Time frame: baseline

  44. Total Energy Expenditure (TEE)

    Time frame: day 21-23

  45. Urinary 6-sulphatoxymelatonin

    Time frame: baseline

    Analysed from spot urine sample

  46. Urinary 6-sulphatoxymelatonin

    Time frame: day 28

    Analysed from spot urine sample

  47. Recent Physical Activity Questionnaire (RPAQ)

    Time frame: baseline

  48. Recent Physical Activity Questionnaire (RPAQ)

    Time frame: day 28

  49. Sleep Hygiene Index (SHI)

    Time frame: baseline

  50. Sleep Hygiene Index (SHI)

    Time frame: day 28

  51. Eating Choices Index (ECI)

    Time frame: baseline

  52. Eating Choices Index (ECI)

    Time frame: day 28

  53. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: baseline

  54. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: day 28

Other outcomes

  1. Dutch Eating Behaviour Questionnaire (DEBQ)

    Time frame: baseline

  2. Women's Health Questionnaire

    Time frame: baseline

    Questionnaire to identify menstrual phase

  3. Women's Health Questionnaire

    Time frame: day 21

    Questionnaire to identify menstrual phase

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

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

Acronym: SLuMBER

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2016
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.