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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep

Intervention / Treatment
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* Behavioral: Sleep Lengthening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Lengthening<br>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<br>* Behaviour change techniques targeting sleep hygiene<br>|
| No Intervention: Control<br>The control group will be asked to resume their normal lifestyle. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Duration | Wrist Actigraphy | baseline | 
| Sleep Duration | Wrist Actigraphy | week 4 | 
| Sleep Quality | Wrist Actigraphy | baseline | 
| Sleep Quality | Wrist Actigraphy | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | baseline | 
| BMI |  | day 28 | 
| Body fat percentage |  | baseline | 
| Body fat percentage |  | day 28 | 
| Blood pressure |  | baseline | 
| Blood pressure |  | day 28 | 
| Fasting blood glucose |  | baseline | 
| Fasting blood glucose |  | day 28 | 
| Fasting total cholesterol |  | baseline | 
| Fasting HDL cholesterol |  | baseline | 
| Fasting LDL cholesterol |  | baseline | 
| Fasting triglycerides |  | baseline | 
| Fasting total cholesterol |  | day 28 | 
| Fasting HDL cholesterol |  | day 28 | 
| Fasting LDL cholesterol |  | day 28 | 
| Fasting triglycerides |  | day 28 | 
| plasma leptin |  | baseline | 
| plasma leptin |  | day 28 | 
| plasma ghrelin |  | baseline | 
| plasma ghrelin |  | day 28 | 
| plasma insulin |  | baseline | 
| plasma insulin |  | day 28 | 
| plasma cortisol |  | baseline | 
| plasma cortisol |  | day 28 | 
| Homeostasis model assessment estimated insulin resistance (HOMA-IR) |  | baseline | 
| Homeostasis model assessment estimated insulin resistance (HOMA-IR) |  | day 28 | 
| Waist circumference |  | baseline | 
| Waist circumference |  | day 28 | 
| Hip circumference |  | baseline | 
| Hip circumference |  | day 28 | 
| Lean body mass |  | baseline | 
| Lean body mass |  | day 28 | 
| Digital volume pulse - Stiffness Index (SI) |  | baseline | 
| Digital volume pulse - Stiffness Index (SI) |  | day 28 | 
| Digital volume pulse - Reflection Index (RI) |  | baseline | 
| Digital volume pulse - Reflection Index (RI) |  | day 28 | 
| Mnemonic Similarity Test (MST) |  | baseline | 
| Mnemonic Similarity Test (MST) |  | day 28 | 
| Dietary Intake (7-day food diary) |  | baseline | 
| Dietary Intake (7-day food diary) |  | week 4 | 
| Resting Metabolic Rate (RMR) |  | baseline | 
| Resting Metabolic Rate (RMR) |  | day 28 | 
| Total Energy Expenditure (TEE) |  | baseline | 
| Total Energy Expenditure (TEE) |  | day 21-23 | 
| Urinary 6-sulphatoxymelatonin | Analysed from spot urine sample | baseline | 
| Urinary 6-sulphatoxymelatonin | Analysed from spot urine sample | day 28 | 
| Recent Physical Activity Questionnaire (RPAQ) |  | baseline | 
| Recent Physical Activity Questionnaire (RPAQ) |  | day 28 | 
| Sleep Hygiene Index (SHI) |  | baseline | 
| Sleep Hygiene Index (SHI) |  | day 28 | 
| Eating Choices Index (ECI) |  | baseline | 
| Eating Choices Index (ECI) |  | day 28 | 
| Pittsburgh Sleep Quality Index (PSQI) |  | baseline | 
| Pittsburgh Sleep Quality Index (PSQI) |  | day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Duration, Sleep Quality, Body Composition, Energy Intake, Energy Expenditure, Energy Balance, Cardiovascular Risk