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

September 13, 2019 updated by: King's College London

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9NH
        • Diabetes & Nutritional Sciences Division, King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sleep Lengthening
The 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.
Behavioral: Sleep Lengthening
Behaviour change techniques targeting sleep hygiene
No Intervention: Control
The control group will be asked to resume their normal lifestyle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sleep Duration
Time Frame: baseline
Wrist Actigraphy
baseline
Sleep Duration
Time Frame: week 4
Wrist Actigraphy
week 4
Sleep Quality
Time Frame: baseline
Wrist Actigraphy
baseline
Sleep Quality
Time Frame: week 4
Wrist Actigraphy
week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: baseline
baseline
BMI
Time Frame: day 28
day 28
Body fat percentage
Time Frame: baseline
baseline
Body fat percentage
Time Frame: day 28
day 28
Blood pressure
Time Frame: baseline
baseline
Blood pressure
Time Frame: day 28
day 28
Fasting blood glucose
Time Frame: baseline
baseline
Fasting blood glucose
Time Frame: day 28
day 28
Fasting total cholesterol
Time Frame: baseline
baseline
Fasting HDL cholesterol
Time Frame: baseline
baseline
Fasting LDL cholesterol
Time Frame: baseline
baseline
Fasting triglycerides
Time Frame: baseline
baseline
Fasting total cholesterol
Time Frame: day 28
day 28
Fasting HDL cholesterol
Time Frame: day 28
day 28
Fasting LDL cholesterol
Time Frame: day 28
day 28
Fasting triglycerides
Time Frame: day 28
day 28
plasma leptin
Time Frame: baseline
baseline
plasma leptin
Time Frame: day 28
day 28
plasma ghrelin
Time Frame: baseline
baseline
plasma ghrelin
Time Frame: day 28
day 28
plasma insulin
Time Frame: baseline
baseline
plasma insulin
Time Frame: day 28
day 28
plasma cortisol
Time Frame: baseline
baseline
plasma cortisol
Time Frame: day 28
day 28
Homeostasis model assessment estimated insulin resistance (HOMA-IR)
Time Frame: baseline
baseline
Homeostasis model assessment estimated insulin resistance (HOMA-IR)
Time Frame: day 28
day 28
Waist circumference
Time Frame: baseline
baseline
Waist circumference
Time Frame: day 28
day 28
Hip circumference
Time Frame: baseline
baseline
Hip circumference
Time Frame: day 28
day 28
Lean body mass
Time Frame: baseline
baseline
Lean body mass
Time Frame: day 28
day 28
Digital volume pulse - Stiffness Index (SI)
Time Frame: baseline
baseline
Digital volume pulse - Stiffness Index (SI)
Time Frame: day 28
day 28
Digital volume pulse - Reflection Index (RI)
Time Frame: baseline
baseline
Digital volume pulse - Reflection Index (RI)
Time Frame: day 28
day 28
Mnemonic Similarity Test (MST)
Time Frame: baseline
baseline
Mnemonic Similarity Test (MST)
Time Frame: day 28
day 28
Dietary Intake (7-day food diary)
Time Frame: baseline
baseline
Dietary Intake (7-day food diary)
Time Frame: week 4
week 4
Resting Metabolic Rate (RMR)
Time Frame: baseline
baseline
Resting Metabolic Rate (RMR)
Time Frame: day 28
day 28
Total Energy Expenditure (TEE)
Time Frame: baseline
baseline
Total Energy Expenditure (TEE)
Time Frame: day 21-23
day 21-23
Urinary 6-sulphatoxymelatonin
Time Frame: baseline
Analysed from spot urine sample
baseline
Urinary 6-sulphatoxymelatonin
Time Frame: day 28
Analysed from spot urine sample
day 28
Recent Physical Activity Questionnaire (RPAQ)
Time Frame: baseline
baseline
Recent Physical Activity Questionnaire (RPAQ)
Time Frame: day 28
day 28
Sleep Hygiene Index (SHI)
Time Frame: baseline
baseline
Sleep Hygiene Index (SHI)
Time Frame: day 28
day 28
Eating Choices Index (ECI)
Time Frame: baseline
baseline
Eating Choices Index (ECI)
Time Frame: day 28
day 28
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: baseline
baseline
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: day 28
day 28

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dutch Eating Behaviour Questionnaire (DEBQ)
Time Frame: baseline
baseline
Women's Health Questionnaire
Time Frame: baseline
Questionnaire to identify menstrual phase
baseline
Women's Health Questionnaire
Time Frame: day 21
Questionnaire to identify menstrual phase
day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SLuMBER Study 2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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