InsomniaPhase 1NCT02043977
Efficacy and Safety Study of Propofol Infusion for Refractory Chronic Primary Insomnia
A Phase 1 study testing propofol injectable emulsion in people with Insomnia and Sleep Disorder, run by Life Extension Foundation Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Sleep Disorder, Dyssomnia
- What is being tested?
- propofol injectable emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to May 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
About this study
Official title: 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.
- Conditions
- Insomnia, Sleep Disorder, Dyssomnia
- Being tested
- propofol injectable emulsion
- Keywords
- Propofol, Insomnia, Sleep disorder, Sleep deprivation, Chronic insomnia, Refractory insomnia, Primary insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders, Dyssomnias, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol injectable emulsionDrug
| Study group | Role | What they receive |
|---|---|---|
| propofol infusion | Experimental | 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. Receives: Drug: propofol injectable emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the scores on the subjective assessment from the Leeds Sleep Evaluation Questionnaire
Measured: 180 days
Mean change in the scores on the objective measurements of sleep architecture and patterns from polysomnography
Measured: 90 days
Secondary outcomes (2)
Changes in the scores on the SF(Short form)-35 quality of life questionnaire
Measured: 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
Laboratory markers including complete blood count/chemistry values. Vital signs including blood pressure, pulse and temperature.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life Extension Foundation Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward A Czinn, M.D., Principal investigator, Anesco North Broward LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043977
- Sponsor's protocol ID
- CL053
- Status last verified
- Aug 2016
- First submitted
- 14 Jan 2014
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
American College of Chest Physicians. Diagnosis and Treatment of Insomnia. http://chestnet.org/accp/pccsu/diagnosis-and-treatment-insomnia?page=0.3. Published September 3, 2007. Accessed February 6, 2012.
Barr J, Egan TD, Sandoval NF, Zomorodi K, Cohane C, Gambus PL, Shafer SL. Propofol dosing regimens for ICU sedation based upon an integrated pharmacokinetic-pharmacodynamic model. Anesthesiology. 2001 Aug;95(2):324-33. doi: 10.1097/00000542-200108000-00011.
PubMed 11506101http://www.drugs.com/pro/propofol
http://www.drugs.com/mmx/propofol.html)
Katz DA, McHorney CA. The relationship between insomnia and health-related quality of life in patients with chronic illness. J Fam Pract. 2002 Mar;51(3):229-35.
PubMed 11978233Mace AE. Sample-Size Determination. New York: Reinhold Publishing Corporation, 1964.
Murphy M, Bruno MA, Riedner BA, Boveroux P, Noirhomme Q, Landsness EC, Brichant JF, Phillips C, Massimini M, Laureys S, Tononi G, Boly M. Propofol anesthesia and sleep: a high-density EEG study. Sleep. 2011 Mar 1;34(3):283-91A. doi: 10.1093/sleep/34.3.283.
PubMed 21358845Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002 Apr;6(2):97-111. doi: 10.1053/smrv.2002.0186.
PubMed 12531146Rabelo FA, Braga A, Kupper DS, De Oliveira JA, Lopes FM, de Lima Mattos PL, Barreto SG, Sander HH, Fernandes RM, Valera FC. Propofol-induced sleep: polysomnographic evaluation of patients with obstructive sleep apnea and controls. Otolaryngol Head Neck Surg. 2010 Feb;142(2):218-24. doi: 10.1016/j.otohns.2009.11.002.
PubMed 20115978Rajput V, Bromley SM. Chronic insomnia: a practical review. Am Fam Physician. 1999 Oct 1;60(5):1431-8; discussion 1441-2.
PubMed 10524487Ringdahl EN, Pereira SL, Delzell JE Jr. Treatment of primary insomnia. J Am Board Fam Pract. 2004 May-Jun;17(3):212-9. doi: 10.3122/jabfm.17.3.212.
PubMed 15226287Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med. 2007 Aug 15;3(5 Suppl):S7-10. No abstract available.
PubMed 17824495Saddichha S. Diagnosis and treatment of chronic insomnia. Ann Indian Acad Neurol. 2010 Apr;13(2):94-102. doi: 10.4103/0972-2327.64628.
PubMed 20814491Tung A, Bergmann BM, Herrera S, Cao D, Mendelson WB. Recovery from sleep deprivation occurs during propofol anesthesia. Anesthesiology. 2004 Jun;100(6):1419-26. doi: 10.1097/00000542-200406000-00014.
PubMed 15166561Tung A, Lynch JP, Mendelson WB. Prolonged sedation with propofol in the rat does not result in sleep deprivation. Anesth Analg. 2001 May;92(5):1232-6. doi: 10.1097/00000539-200105000-00028.
PubMed 11323352
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Pilot Study Utilizing an IV Infusion of Propofol in Male and Female Volunteers With Refractory Chronic Primary Insomnia
- ClinicalTrials.gov ID
- NCT02043977
- Acronym / sponsor ID
- CL053
- Conditions
- Insomnia, Sleep Disorder, Dyssomnia
- Keywords
- Propofol, Insomnia, Sleep disorder, Sleep deprivation, Chronic insomnia, Refractory insomnia, Primary insomnia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Life Extension Foundation Inc.University, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| propofol infusion | Experimental | Drug: propofol injectable emulsionInduction 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol injectable emulsion | Drug | propofol infusion |
Primary outcome
Mean change in the scores on the subjective assessment from the Leeds Sleep Evaluation Questionnaire
Time frame: 180 days
Mean change in the scores on the objective measurements of sleep architecture and patterns from polysomnography
Time frame: 90 days
2 secondary outcomes
Changes in the scores on the SF(Short form)-35 quality of life questionnaire
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- BackgroundAmerican College of Chest Physicians. Diagnosis and Treatment of Insomnia. http://chestnet.org/accp/pccsu/diagnosis-and-treatment-insomnia?page=0.3. Published September 3, 2007. Accessed February 6, 2012.
- Background: PubMed 11506101Barr J, Egan TD, Sandoval NF, Zomorodi K, Cohane C, Gambus PL, Shafer SL. Propofol dosing regimens for ICU sedation based upon an integrated pharmacokinetic-pharmacodynamic model. Anesthesiology. 2001 Aug;95(2):324-33. doi: 10.1097/00000542-200108000-00011.
- Backgroundhttp://www.drugs.com/pro/propofol
- Backgroundhttp://www.drugs.com/mmx/propofol.html)
- Background: PubMed 11978233Katz DA, McHorney CA. The relationship between insomnia and health-related quality of life in patients with chronic illness. J Fam Pract. 2002 Mar;51(3):229-35.
- BackgroundMace AE. Sample-Size Determination. New York: Reinhold Publishing Corporation, 1964.
- Background: PubMed 21358845Murphy M, Bruno MA, Riedner BA, Boveroux P, Noirhomme Q, Landsness EC, Brichant JF, Phillips C, Massimini M, Laureys S, Tononi G, Boly M. Propofol anesthesia and sleep: a high-density EEG study. Sleep. 2011 Mar 1;34(3):283-91A. doi: 10.1093/sleep/34.3.283.
- Background: PubMed 12531146Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002 Apr;6(2):97-111. doi: 10.1053/smrv.2002.0186.
- Background: PubMed 20115978Rabelo FA, Braga A, Kupper DS, De Oliveira JA, Lopes FM, de Lima Mattos PL, Barreto SG, Sander HH, Fernandes RM, Valera FC. Propofol-induced sleep: polysomnographic evaluation of patients with obstructive sleep apnea and controls. Otolaryngol Head Neck Surg. 2010 Feb;142(2):218-24. doi: 10.1016/j.otohns.2009.11.002.
- Background: PubMed 10524487Rajput V, Bromley SM. Chronic insomnia: a practical review. Am Fam Physician. 1999 Oct 1;60(5):1431-8; discussion 1441-2.
- Background: PubMed 15226287Ringdahl EN, Pereira SL, Delzell JE Jr. Treatment of primary insomnia. J Am Board Fam Pract. 2004 May-Jun;17(3):212-9. doi: 10.3122/jabfm.17.3.212.
- Background: PubMed 17824495Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med. 2007 Aug 15;3(5 Suppl):S7-10. No abstract available.
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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.
Edward A Czinn, M.D. principal investigator
Anesco North Broward LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing propofol injectable emulsion in people with Insomnia and Sleep Disorder, run by Life Extension Foundation Inc. 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 11 inclusion and 18 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 30 Aug 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change in the scores on the subjective assessment from the Leeds Sleep Evaluation Questionnaire (time frame: 180 days). 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 NCT02043977, which also lists 17 linked publications.
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 30 Aug 2016.