Stress and Insomnia

NCT02591303 | Completed

• 1 other identifier: CHUBX 2015/12
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Stress

Keywords

Insomnia; Stress; Real-life stressful events

Outcome Measures

Primary Outcomes (3)

• Heart rate variability at the stressful event

  Day 19 after pre-inclusion

• 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

  Day 19 after pre-inclusion

• Reaction times at the stressful event

  Day 19 after pre-inclusion

Secondary Outcomes (11)

• Total sleep time by polysomnography

  Days 17, 18 and 19 after pre-inclusion

• Rapid Eye Movement (REM) duration by polysomnography

  Days 17, 18 and 19 after pre-inclusion

• Non-Rapid Eye Movement (NREM) duration by polysomnography

  Days 17, 18 and 19 after pre-inclusion

• Sleep spindle density by polysomnography

  Days 17, 18 and 19 after pre-inclusion

• Total sleep time obtained by actimetry

  Every night between pre-inclusion and Day 20 (study termination)

Study Arms (2)

Insomnia group

EXPERIMENTAL

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

Other: Stress reactions measurement during stressful and neutral driving sessions

Control group

EXPERIMENTAL

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

Other: Stress reactions measurement during stressful and neutral driving sessions

Interventions

Stress reactions measurement during stressful and neutral driving sessions OTHER

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.

Control group; Insomnia group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• years old
• Female
• Having given written informed consent to participate in the research project
• Driving license

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Labex Brain: collaborator

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 29, 2015
• Study Start: November 3, 2015
• Primary Completion: September 15, 2016
• Study Completion: September 15, 2016
• Last Updated: August 23, 2017

Record last verified: 2017-08

Locations

FR (1)