Chronic InsomniaNCT02048878

Hyper-Arousal in Chronic Primary Insomnia

An observational study of Chronic Insomnia, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Insomnia
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Jan 2014to 20 Dec 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Insomniacs and good sleepers

Who may be able to join

Men and women with primary insomnia of at least 3 months in duration
ages 21-65 years old
BMI <35 kg/m2 to enable microneurography
Moderate to severe insomnia based on the Insomnia Severity Index (ISI) questionnaire
Pittsburgh Sleep Quality Index (PSQI) > 5
Self-reported habitual sleep duration < 6.5 hours

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21-65 years old men and women with BMI <35 kg/m2
No insomnia based on ISI questionnaire
Self-reported habitual sleep duration ≥ 6.5 hours but < 9 hours
PSQI<5
Sleep efficiency on PSG with TRT of 8 hours > 85%
No history of mental illness, shift work, circadian rhythm disorders

Who cannot join

Sleep disorders other than insomnia as assessed by screening PSG (apnea-hypopnea index or AHI ≥ 10, PLM arousal index ≥ 5)
Circadian rhythm sleep disorders
Diabetic based on HbA1c ≥ 6.5 %. For those with HbA1c ≥ 6.0 but <6.5%, the non-diabetic condition will be confirmed by 2-h oral glucose tolerance test
History of meeting DSM-IVR criteria based on the Mini International Neuropsychiatric Interview version 6.0 for any major psychiatric disorder
Unstable or serious medical conditions
Current, or use within the past month, of psychoactive (other than stable treatment with antidepressants), hypnotic, stimulant or analgesic medications (except occasional non-narcotic analgesics), beta blockers or alpha blockers

Show all 10Show fewer

Shift work or other types of self imposed irregular sleep schedules
Habitual smoking
Habitual alcohol consumption
Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Chicago
Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Multi-Level Assessment of Physiologic Hyper-Arousal in Chronic Primary Insomnia: A Case Control Study

The purpose of this study is to determine whether individuals with chronic insomnia disorder have a higher degree of physiologic arousal (resulting in their trouble sleeping) than good sleepers. The primary goal is to perform a rigorous quantitative assessment of physiologic hyper-arousal across two domains (autonomic nervous system and neurophysiology) in patients with chronic primary insomnia as compared to good sleepers matched for sex, age, body mass index (BMI) and race/ethnicity.

Conditions: Chronic Insomnia
Keywords: Insomnia
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02048878
Study group	Role	What they receive
Insomnia group		Assessment of physiologic hyper-arousal across the two following domains: 1. Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness. 2. Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis.
Matched Control Group		Assessment of physiologic hyper-arousal across the two following domains: 1. Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness. 2. Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis.

What is being measured

The primary outcome is the main question the study is designed to answer.

Sympathetic Baroreflex Sensitivity (BRS) Unit
Direct recording of sympathetic nervous activity in a nerve of the lower leg using a micro-electrode.
Measured: 2 months after enrollment
Systolic Arterial Pressure Reactivity
Increase in blood pressure to stress
Measured: within 2 months after enrollment

Secondary outcomes (4)

Multiple Sleep Latency Test (MSLT)
MSLT will be used to objectively quantify tendency to fall asleep (sleep latency).
Measured: 2 months of enrollment
Heart Rate Variability During Wake and During Sleep
The balance between sympathetic and parasympathetic nervous control of the heart will be determined by spectral analysis of heart rate variability using continuous electrocardiogram (ECG) recording for 24 hours, including the normal sleep period.
Measured: 2 months after enrollment
Electroencephalography (EEG) During Wake and Sleep
The EEG will be measured continuously during sleep and at frequent intervals during wake. The signal will be submitted to power spectral analysis to examine spectral power in frequency bands that are typical of arousal and in frequency bands that are typical of deep sleep.
Measured: 2 months of enrollment
Noninvasive Beat-to-beat Blood Pressure Monitoring
Measured: 2 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201420 Dec 2016

First posted29 Jan 2014 (estimated)
Study startJan 2014
Primary completion9 Dec 2016
Study completion20 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic InsomniaStudies of the same condition, open and under way.
More trials run by University of ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02048878
Sponsor's protocol ID: 13-1214
Status last verified: Jan 2020
First submitted: 27 Jan 2014
Last updated: 18 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Carter JR, Grimaldi D, Fonkoue IT, Medalie L, Mokhlesi B, Cauter EV. Assessment of sympathetic neural activity in chronic insomnia: evidence for elevated cardiovascular risk. Sleep. 2018 Jun 1;41(6):zsy048. doi: 10.1093/sleep/zsy048.
PubMed 29522186

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Level Assessment of Physiologic Hyper-Arousal in Chronic Primary Insomnia: A Case Control Study
ClinicalTrials.gov ID: NCT02048878
Acronym / sponsor ID: 13-1214
Conditions: Chronic Insomnia
Keywords: Insomnia
Study type: Observational
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Study start: Jan 2014
Primary completion: 9 Dec 2016 (actual)
Study completion: 20 Dec 2016 (actual)
First posted: 29 Jan 2014 (estimated)
Results: Posted 18 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Insomnia group	–	–Assessment of physiologic hyper-arousal across the two following domains: 1. Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness. 2. Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis.
Matched Control Group	–	–Assessment of physiologic hyper-arousal across the two following domains: 1. Sympathetic neural activity: recording at the level of the muscle by microneurography and at the level of the heart by spectral analysis of heart rate variability from the ECG signal obtained during sleep and wakefulness. 2. Neurophysiologic arousal: recording of multiple sleep latency test (MSLT), recording of wake electroencephalography (EEG), and quantitative sleep EEG recording and analysis.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Insomniacs and good sleepers

Key inclusion criteria (12 listed)

Men and women with primary insomnia of at least 3 months in duration
ages 21-65 years old
BMI <35 kg/m2 to enable microneurography
Moderate to severe insomnia based on the Insomnia Severity Index (ISI) questionnaire
Pittsburgh Sleep Quality Index (PSQI) > 5

Key exclusion criteria (10 listed)

Sleep disorders other than insomnia as assessed by screening PSG (apnea-hypopnea index or AHI ≥ 10, PLM arousal index ≥ 5)
Circadian rhythm sleep disorders
Diabetic based on HbA1c ≥ 6.5 %. For those with HbA1c ≥ 6.0 but <6.5%, the non-diabetic condition will be confirmed by 2-h oral glucose tolerance test
History of meeting DSM-IVR criteria based on the Mini International Neuropsychiatric Interview version 6.0 for any major psychiatric disorder
Unstable or serious medical conditions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Sympathetic Baroreflex Sensitivity (BRS) Unit
Time frame: 2 months after enrollment
Direct recording of sympathetic nervous activity in a nerve of the lower leg using a micro-electrode.
Systolic Arterial Pressure Reactivity
Time frame: within 2 months after enrollment
Increase in blood pressure to stress

4 secondary outcomes

Multiple Sleep Latency Test (MSLT)
Time frame: 2 months of enrollment
Heart Rate Variability During Wake and During Sleep
Time frame: 2 months after enrollment
Electroencephalography (EEG) During Wake and Sleep
Time frame: 2 months of enrollment
Noninvasive Beat-to-beat Blood Pressure Monitoring
Time frame: 2 months after enrollment

Results and safety

Results posted to the registry on 18 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insomnia Group	13	12
Matched Control Group	15	12

Primary outcome: Sympathetic Baroreflex Sensitivity (BRS) Unit

Time frame: 2 months after enrollment. Mean (Standard Deviation). Unit: bursts per 100 heart beats per mm Hg

Measure	Insomnia Group n = 12	Matched Control Group n = 12
Value	-2.1 (1.0)	-4.3 (1.3)

Primary outcome: Systolic Arterial Pressure Reactivity

Time frame: within 2 months after enrollment. Mean (Standard Deviation). Unit: mmHg

Measure	Insomnia Group n = 12	Matched Control Group n = 12
Value	21 (11)	14 (8)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insomnia Group	0 of 12 (0%)	0 of 12 (0%)	Not reported
Matched Control Group	0 of 12 (0%)	0 of 12 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29522186Carter JR, Grimaldi D, Fonkoue IT, Medalie L, Mokhlesi B, Cauter EV. Assessment of sympathetic neural activity in chronic insomnia: evidence for elevated cardiovascular risk. Sleep. 2018 Jun 1;41(6):zsy048. doi: 10.1093/sleep/zsy048.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eve Van Cauter, PhD principal investigator

University of Chicago

Babak Mokhlesi, MD principal investigator

University of Chicago

Jason R Carter, PhD principal investigator

Michigan Technological University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Insomnia, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sympathetic Baroreflex Sensitivity (BRS) Unit (time frame: 2 months after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02048878, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.