Stress and Insomnia

NCT ID: NCT02591303

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-03
• Study Completion Date: 2016-09-15

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Insomnia group

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

Group Type: EXPERIMENTAL

Stress reactions measurement during stressful and neutral driving sessions

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Stress reactions measurement during stressful and neutral driving sessions

Intervention Type: 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.

Interventions

Stress reactions measurement during stressful and neutral driving sessions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Labex Brain

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2015/12

Identifier Type: -

Identifier Source: org_study_id