Efficacy and Safety Study of Propofol Infusion for Refractory Chronic Primary Insomnia

August 26, 2016 updated by: Life Extension Foundation Inc.

An Open Label, Pilot Study Utilizing an IV Infusion of Propofol in Male and Female Volunteers With Refractory Chronic Primary Insomnia

Insomnia is a widespread condition in which approximately one-third of adults in the United States are symptomatic with 6% of the population meeting the diagnostic criteria for insomnia. There is an increased risk of insomnia in certain segments of the population including women, middle-aged and older adults, shift workers and individuals with medical or psychiatric disorders. Individuals with insomnia have a decreased quality of life compared to those who report other serious illnesses such as major depression and congestive heart failure. Chronic insomnia can be caused by medications, drug or alcohol abuse, psychiatric disorders, medical and neurologic disorders. It can impair cognitive and physical functioning.

Propofol is an approved drug administered intravenously for use in the induction and maintenance of anesthesia or sedation. Some research suggests that propofol when administered as a two hour infusion may improve the ease of sleep onset, sleep quality, ease of awakening and the integrity of behavior following waking.

This study will be conducted in the Broward Health Medical Center Sleep Lab, under the direct care of a Board Certified Anesthesiologist, dedicated to the study involving participants who have refractory chronic primary insomnia and have not responded to conventional pharmacologic therapies within the past 90 days. Each qualifying participant will receive an IV infusion of the study medication for 5 consecutive nights. Assessments including polysomnography with completion of questionnaires will occur at screening, Days 1 through 5 of study product administration, Day 6 and Day 90. Follow-up questionnaires will also be distributed on Day 180.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward Health Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ambulatory, male or non-pregnant, non-lactating female, 18-65 years of age.
  • Overall healthy with no other sleep disorder such as sleep apnea or periodic limb movement disorder
  • Has not responded to conventional pharmacologic therapies (benzodiazepines and non-benzodiazepines) within the past 90 days. The non-benzodiazepine therapies can include melatonin and melatonin receptor agonists, antihistamines, antidepressants, over-the-counter medications, supplements or herbs for sleep
  • Have refractory chronic primary insomnia (chronic-inadequate quantity or quality of sleep characterized by a subjective report of difficulty with sleep initiation, duration, consolidation, or quality that occurs despite adequate opportunity for sleep, and results in some form of daytime impairment and has persisted for at least one month., primary-insomnia independent of any known physical or mental condition, refractory-not yielding, at least not yielding readily to treatment based upon polysomnography at baseline, total sleep time (sTST) of < 6 hr, a subjective wake time after sleep onset (WASO) of >1 hr, a subjective latency to sleep onset (SOL) of > 20 min
  • Willing and able to give written informed consent
  • Clearly understands the procedures and requirements for the study
  • Willing and able to comply with all study procedures and data recording obligations for the entire length of the study
  • Have no clinically significant abnormalities on the basis of medical history, physical examination and vital signs in the judgment of the investigator and/or sub-investigator
  • Ability and willingness to abstain from any pharmaceutical or over-the-counter medication for sleep as well as alcohol from 72 hours prior to baseline and the first dose until after completion of the Study Product Administration Follow-Up Visit (Day 6) as well as 72 hours prior to the Day 90 visit.
  • All values for hematology and for clinical chemistry tests of blood within the normal range for age and gender or showing no clinically relevant deviations as judged by the investigator
  • Nonsmoking or have quit smoking at least 6 months prior to dosing

Exclusion Criteria:

  • Having any medical conditions including diabetes, cardiovascular disease, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric (including depression), immunologic, hematologic, gastrointestinal or metabolic disease requiring medical treatment that would preclude participation into the study in the judgment of the investigator/sub-investigator
  • Having ingested any pharmaceutical or over-the-counter sleep product within 72 hours of dosing as well as 72 hours prior to the Day 90 visit.
  • Taking any medication that can yield a moderate to major drug interaction with propofol including those with CNS (central nervous system)-depressant effects
  • Having had a history of any medical or surgical procedure that would preclude participation into the study in the judgment of the investigator/sub-investigator
  • Being pregnant, planning on becoming pregnant, breast feeding or unwilling to use a medically acceptable form of birth control during the study (with at least one acceptable barrier for a period of one month prior to the beginning of the study until at least three months after study completion) or are surgically sterile or postmenopausal (at least 12 months without a period).
  • Having a systolic blood pressure >160 mmHg, diastolic blood pressure >90 mmHg, or blood pressure that would preclude participation in the judgment of the investigator/sub-investigator
  • Having a previous history of abnormal screening laboratory test values: bilirubin > 2 x ULN (upper limit of normal), AST(aspartate aminotransferase) and ALT (alanine aminotransferase) > 2 x ULN (upper limit of normal), serum creatinine > 1.5 mg/dl, fasting blood glucose below 85mg/dl or above 110 mg/dl, calcium level < 8.6 mg/dl and triglycerides >200.0mg/dl.
  • Any type of active malignancy (except non-melanomatous skin malignancies) within the past 5 years
  • History of known or suspected substance abuse
  • Currently consume more than 7 standard alcoholic drinks per week and unable to refrain from consuming an alcoholic beverage during the course of the study dosing period.
  • Currently consume more than 14 caffeinated beverages per week and unable to refrain from consuming a caffeinated beverage within 8 hours prior to dosing.
  • History of allergy to any anesthetic, eggs, egg products, soybeans or soy products as well as hypersensitivity to Propofol or any of its components
  • Unable to avoid engaging in a hazardous occupation requiring complete mental alertness and/or motor coordination after receiving the study product.
  • Participation in another study within 30 days prior to dosing.
  • Donated blood within 30 days prior to dosing.
  • Illness within five days prior to dosing
  • Having a pacemaker or any internal medical device
  • In the opinion of the investigator, not suitable for entry into the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: propofol infusion
Induction of sleep is accomplished with a bolus of propofol (up to 0.5mg/kg over one minute, concurrently with a constant infusion of propofol starting at 25 ug/kg/min titrated to a maximum of 100ug/kg/min, to maintain the subject at a Modified Ramsay Score of 3-4 for a total of 120 minutes. An additional bolus may be given by the investigator in order to maintain the level of sleep. This procedure will be conducted over 5 consecutive nights.
Drug: propofol injectable emulsion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in the scores on the subjective assessment from the Leeds Sleep Evaluation Questionnaire
Time Frame: 180 days
180 days
Mean change in the scores on the objective measurements of sleep architecture and patterns from polysomnography
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the scores on the SF(Short form)-35 quality of life questionnaire
Time Frame: 180 days
180 days
Changes in safety parameters from the propofol infusion compared to baseline measured by laboratory markers, vital signs, electrocardiogram, pulse oximeter, physical exam and any adverse events
Time Frame: 5 days
Laboratory markers including complete blood count/chemistry values. Vital signs including blood pressure, pulse and temperature.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Life Extension Foundation Inc.

Investigators

  • Principal Investigator: Edward A Czinn, M.D., Anesco North Broward LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 26, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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