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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02787577
Acronym
SLuMBER
Enrollment
43
Registered
2016-06-01
Start date
2016-04-30
Completion date
2016-12-31
Last updated
2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

Sleep Duration, Sleep Quality, Body Composition, Energy Intake, Energy Expenditure, Energy Balance, Cardiovascular Risk

Brief 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. 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.

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.

Interventions

BEHAVIORALSleep Lengthening

Behaviour change techniques targeting sleep hygiene

Sponsors

King's College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sleep DurationbaselineWrist Actigraphy
Sleep QualitybaselineWrist Actigraphy

Secondary

MeasureTime frameDescription
Body fat percentagebaseline
Blood pressurebaseline
Fasting blood glucosebaseline
Fasting total cholesterolbaseline
Fasting HDL cholesterolbaseline
Fasting LDL cholesterolbaseline
Fasting triglyceridesbaseline
plasma leptinbaseline
plasma ghrelinbaseline
plasma insulinbaseline
plasma cortisolbaseline
Homeostasis model assessment estimated insulin resistance (HOMA-IR)baseline
Hip circumferencebaseline
Lean body massbaseline
Digital volume pulse - Stiffness Index (SI)baseline
Digital volume pulse - Reflection Index (RI)baseline
Mnemonic Similarity Test (MST)baseline
Dietary Intake (7-day food diary)baseline
Resting Metabolic Rate (RMR)baseline
Total Energy Expenditure (TEE)baseline
Urinary 6-sulphatoxymelatoninbaselineAnalysed from spot urine sample
Recent Physical Activity Questionnaire (RPAQ)baseline
Sleep Hygiene Index (SHI)baseline
Eating Choices Index (ECI)baseline
Pittsburgh Sleep Quality Index (PSQI)baseline
Waist circumferencebaseline
BMIbaseline

Other

MeasureTime frameDescription
Dutch Eating Behaviour Questionnaire (DEBQ)baseline
Women's Health QuestionnairebaselineQuestionnaire to identify menstrual phase

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026