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Stress and Insomnia (StresSleep)

Primary Purpose

Insomnia, Stress

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Stress reactions measurement during stressful and neutral driving sessions
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insomnia focused on measuring Insomnia, Stress, Real-life stressful events

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Insomnia group: patients with insomnia (DSM-V criteria): sleep complaints, of more than 3 nights a week, more than 3 months, affected daytime functioning
  • Control group: no self-reported sleep problems
  • 20-50 years old
  • Female
  • Having given written informed consent to participate in the research project
  • Driving license

Exclusion Criteria:

  • Night and shift-workers,
  • Psychiatric disorder: clinical mood disorder, anxiety disorder, psychosis, bipolar disorder,
  • For insomnia group: all sleep disorders other than persistent insomnia,
  • For control group: all sleep disorders
  • Progressive neurological diseases that include restless legs syndrome,
  • Cardiovascular disease other than treated hypertension,
  • Unstable respiratory or endocrinological diseases,
  • Reporting symptoms of menopause and/or taking hormone replacement therapy for menopause symptoms,
  • Drug addiction, alcohol addiction during the previous 6 months (smoking is allowed),
  • Having undertaken trans-meridian travel (± 3H) in the previous 1 month,
  • Pregnant or lactating women.
  • Chronic pain.
  • Having simulator-sickness during the first practice session
  • Hypnotic and psychotropic medication taking or stopped less than 5 half-life periods of molecules before screening V0.
  • A change in skin conductance of less than 0.05 microSiemens after an auditory stimulus.
  • Left-handedness
  • Patient participating to any other interventional study

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Insomnia group

Control group

Arm Description

Patients with insomnia: sleep complaints, of more than 3 nights a week, more than 3 months, affected daytime functioning, objectified low sleep quality (Sleep Efficiency <85%) with 10 days actigraphy

No sleep problems either self reported or objectified through actigraphy (Sleep Efficiency >85%)

Outcomes

Primary Outcome Measures

Heart rate variability at the stressful event
Skin conductance changes at the stressful event
Electrodermal responsiveness is defined as a change in skin conductance with a minimum amplitude of 0.05 microSiemens
Reaction times at the stressful event

Secondary Outcome Measures

Total sleep time by polysomnography
Rapid Eye Movement (REM) duration by polysomnography
Non-Rapid Eye Movement (NREM) duration by polysomnography
Sleep spindle density by polysomnography
Total sleep time obtained by actimetry
Sleep efficiency obtained by actimetry
Wake after sleep onset obtained by actimetry
Sleep latency obtained by actimetry
Visual analogue scale for driving stressfulness
Presleep State Arousal Scale
PostTraumatic Stress Disorder checklist

Full Information

First Posted
October 16, 2015
Last Updated
August 22, 2017
Sponsor
University Hospital, Bordeaux
Collaborators
Labex Brain
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1. Study Identification

Unique Protocol Identification Number
NCT02591303
Brief Title
Stress and Insomnia
Acronym
StresSleep
Official Title
Stress and Insomnia: Investigating a Bidirectional Relation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 3, 2015 (Actual)
Primary Completion Date
September 15, 2016 (Actual)
Study Completion Date
September 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Labex Brain

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Insomnia is characterized by rumination and worry over stressful events affecting nighttime sleep. Emotional reactions while stressful events are ongoing have not often been investigated in insomnia. In the current study stress reactions will be measured during a real-life simulation experiment with stressful events and investigate not only how previous sleep patterns affect emotional reactivity to the event but also how the emotional events affect sleep patterns the following night. Thirty-six female subjects (age 25-45 years) without sleep complaints (n=18) or with insomnia (n=18) will enroll in a interventional study measuring the reaction to and effects of either neutral or stressful events during driving. Through questionaires and intake polysomnography, clinical levels of depression and anxiety will be excluded as well as sleep medication use and alternative sleep disorders than insomnia. Stress levels will be measured through skin conductance and heart rate variability during events and through nighttime polysomnography (PSG). Effects on sleep architecture and arousal levels will be measured through nighttime PSG. Investigators hypothesize that subjects with insomnia, compared to subjects without sleep complaints, show stronger emotional reactions to stressful events and stronger effects of stress on sleep quality the following night. Results will facilitate a model for emotional reactivity in chronic sleep disruption which may aid to prevent short term sleep disruption converting into chronic insomnia and aid in developing customized insomnia treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Stress
Keywords
Insomnia, Stress, Real-life stressful events

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insomnia group
Arm Type
Experimental
Arm Description
Patients with insomnia: sleep complaints, of more than 3 nights a week, more than 3 months, affected daytime functioning, objectified low sleep quality (Sleep Efficiency <85%) with 10 days actigraphy
Arm Title
Control group
Arm Type
Experimental
Arm Description
No sleep problems either self reported or objectified through actigraphy (Sleep Efficiency >85%)
Intervention Type
Other
Intervention Name(s)
Stress reactions measurement during stressful and neutral driving sessions
Intervention Description
Stress effects will be measured during 3 driving sessions (training without events on Day 17, with neutral events on Day 18, with stressful events on Day19), through nighttime PSG and questionnaires.
Primary Outcome Measure Information:
Title
Heart rate variability at the stressful event
Time Frame
Day 19 after pre-inclusion
Title
Skin conductance changes at the stressful event
Description
Electrodermal responsiveness is defined as a change in skin conductance with a minimum amplitude of 0.05 microSiemens
Time Frame
Day 19 after pre-inclusion
Title
Reaction times at the stressful event
Time Frame
Day 19 after pre-inclusion
Secondary Outcome Measure Information:
Title
Total sleep time by polysomnography
Time Frame
Days 17, 18 and 19 after pre-inclusion
Title
Rapid Eye Movement (REM) duration by polysomnography
Time Frame
Days 17, 18 and 19 after pre-inclusion
Title
Non-Rapid Eye Movement (NREM) duration by polysomnography
Time Frame
Days 17, 18 and 19 after pre-inclusion
Title
Sleep spindle density by polysomnography
Time Frame
Days 17, 18 and 19 after pre-inclusion
Title
Total sleep time obtained by actimetry
Time Frame
Every night between pre-inclusion and Day 20 (study termination)
Title
Sleep efficiency obtained by actimetry
Time Frame
Every night between pre-inclusion and Day 20 (study termination)
Title
Wake after sleep onset obtained by actimetry
Time Frame
Every night between pre-inclusion and Day 20 (study termination)
Title
Sleep latency obtained by actimetry
Time Frame
Every night between pre-inclusion and Day 20 (study termination)
Title
Visual analogue scale for driving stressfulness
Time Frame
Days 17, 18 and 19 after pre-inclusion
Title
Presleep State Arousal Scale
Time Frame
Days 10, 18, 19 and 20 after pre-inclusion
Title
PostTraumatic Stress Disorder checklist
Time Frame
Day 20

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Insomnia group: patients with insomnia (DSM-V criteria): sleep complaints, of more than 3 nights a week, more than 3 months, affected daytime functioning Control group: no self-reported sleep problems 20-50 years old Female Having given written informed consent to participate in the research project Driving license Exclusion Criteria: Night and shift-workers, Psychiatric disorder: clinical mood disorder, anxiety disorder, psychosis, bipolar disorder, For insomnia group: all sleep disorders other than persistent insomnia, For control group: all sleep disorders Progressive neurological diseases that include restless legs syndrome, Cardiovascular disease other than treated hypertension, Unstable respiratory or endocrinological diseases, Reporting symptoms of menopause and/or taking hormone replacement therapy for menopause symptoms, Drug addiction, alcohol addiction during the previous 6 months (smoking is allowed), Having undertaken trans-meridian travel (± 3H) in the previous 1 month, Pregnant or lactating women. Chronic pain. Having simulator-sickness during the first practice session Hypnotic and psychotropic medication taking or stopped less than 5 half-life periods of molecules before screening V0. A change in skin conductance of less than 0.05 microSiemens after an auditory stimulus. Left-handedness Patient participating to any other interventional study
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

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