Sleep RestrictionNCT00895570
The Effects of Modafinil to Counteract the Adverse Metabolic Consequences of Sleep Restriction
A study testing modafinil in people with Sleep Restriction and Impaired Glucose Metabolism, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of the study is to examine the effects of sleep and modafinil on how the body processes glucose. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Restriction, Impaired Glucose Metabolism
- What is being tested?
- modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Apr 2007
- Phase
- Interventional
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must have also demonstrated a full understanding of the requirements and demands of the study.
- Individuals must have been willing to follow a regular sleep-wake schedule.
Who cannot join
- Sleep/wake history. During completion of the preliminary telephone and written screening questionnaires, potential volunteers were asked a number of questions about their present, past and desired habitual sleep/wake schedule, including their habitual and desired bedtimes, wake-times, and nap times. Those potential volunteers with a history of night-work in the preceding 3-year period or travel across >2 time zones in the 3 months prior to the study were excluded.
- Individuals who are unable or unwilling to follow a regular sleep-wake schedule were excluded from the study.
- Drug/Alcohol Use. Volunteers must have been drug-free (including nicotine) and with moderate or no use of caffeine or alcohol for the entire duration of the study. No medications (prescription or over the counter) that significantly affect circadian rhythms, endocrine physiology, or sleep were allowed. They must have had no history of drug or alcohol dependency. No caffeine or alcohol were allowed for one week prior to or during the inpatient portion of the protocol. A comprehensive toxicological analysis of blood and urine for prescription medication, non-prescription medication, drugs of abuse, and caffeine, nicotine and alcohol metabolites was carried out for verification of reported non-use during the initial screening and on the day of admission to the laboratory for verification.
- Evaluation of Medical Suitability. Only healthy, non-obese men were selected for this study. Subjects must have been free from any acute, chronic or debilitating medical conditions. Normality was established on the basis of clinical history, electrocardiogram, clinical biochemical screening tests of blood and urine, and a physical examination conducted by a licensed physician. Any subject with symptoms of active illness (e.g., fever, leukocytosis, hypertension) was excluded from study. Given the wide range of illnesses that are encountered in medical practice, it would not be possible to provide a comprehensive list of each and every disease that could serve as grounds for exclusion for the subject. However, the following is a list of illnesses that would certainly have been grounds for exclusion: Chronobiologic Disorders, Sleep Disorders, Diseases of the Cardiovascular System, Disorders of the Kidney and Urinary Tract, Infectious Diseases, Disorders of the Gastrointestinal System, Disorders of the Immune System, Connective Tissue and Joints, Disorders of the Hematopoietic System, Neoplastic Diseases, Endocrine and Metabolic Diseases, Neurologic Disorders; significant impairments of the visual system.
- Evaluation of Psychiatric/Psychological Suitability. Each potential volunteer completed a series of psychological questionnaires received a comprehensive psychological examination by a clinical psychologist experienced with the psychological screening for the subjects in our studies. Individuals with evidence of psychopathology on standardized questionnaires or in a structured interview were excluded from study. Individuals with a history of psychiatric illnesses or psychiatric disorders were excluded. Individuals who are unaware of specific psychiatric diagnoses who have a history of having been treated with antidepressant, neuroleptic medications or major tranquilizers were excluded from study. However, a personal history of limited prior counseling or psychotherapy (e.g., for adjustment reactions) was not necessarily exclusionary. Potential subjects were evaluated for Axis II personality types that might interfere with protocol compliance or with their personal ability to tolerate the conditions of the study, such as temporal isolation and confinement.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Sleep Restriction, Impaired Glucose Metabolism, and Performance: The Effects of Modafinil to Counteract the Adverse Metabolic Consequences of Sleep Restriction
The purpose of the study is to examine the effects of sleep and modafinil on how the body processes glucose.
Read the detailed description
The occurrence and diagnosis of DM2 and its complications is increasing, leading to rising treatment costs that represent a considerable portion of the U.S. health care budget. Although treatment of impaired glucose tolerance (IGT) is not common, an IGT diagnosis increases the likelihood of progression to DM2. Careful attention to glycemic control is a primary treatment goal for DM2 patients, as glucose control reduces the severity of microvascular, macrovascular, and other complications.
Recent research has indicated that sleep loss could be a previously unrecognized risk factor for DM2. As sleep restriction has become an endemic condition in developed countries, it is possible that sleep loss contributes to the recent epidemic of DM2. Protecting sleep by increasing sleep duration and quality in DM2 and IGT patients may provide an inexpensive, relatively easy to implement intervention to reduce the risk of disease onset or delay disease progression by improving glucose tolerance. Furthermore, measurement of endocrine, metabolic, and cardiovascular parameters in the proposed studies may provide insights into the mechanisms by which sleep extension improves glucose tolerance under pathophysiological conditions.
The proposed study examines and quantifies in adults the link between insufficient sleep and increased insulin resistance, impaired insulin secretion, and reduced non-insulin-dependent glucose utilization by the sleepy brain. The proposed study capitalizes upon the unique pharmacological characteristics of modafinil to reverse excessive sleepiness to address the mechanisms by which sleep restriction may impact metabolism via excessive sleepiness. This study may lead to countermeasures to the adverse health impact of chronic insufficient sleep, an increasingly common lifestyle that may ultimately contribute to the development of the Metabolic Syndrome or DM2 via alterations of glucose metabolism and brain glucose utilization.
- Conditions
- Sleep Restriction, Impaired Glucose Metabolism
- Being tested
- modafinil, placebo
- Keywords
- sleep restriction, glucose metabolism, modafinil, euglycemic clamp, insulin sensitivity, insulin release
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modafinilDrug
Also called Provigil
During each day of the 7-day sleep restriction phase of the study modafinil was administered (200 mg tablet at 0600, and a second dose of 100 mg tablet at 1300).
placeboDrug
During each day of the 7-day sleep restriction phase of the study a sugar pill was administered.
| Study group | Role | What they receive |
|---|---|---|
| Modafinil | Experimental | During each day of the 7-day sleep restriction phase of the study modafinil was administered (200 mg tablet at 0600, and a second dose of 100 mg tablet at 1300). Receives: Drug: modafinil |
| Placebo | Placebo comparator | During each day of the 7-day sleep restriction phase of the study a sugar pill was administered. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity measured with euglycemic hyperinsulinemic clamp
Measured: Following 3 nights of a continued 'sleep replete' period with 10 hours/night of time in bed and again following 7 days sleep restricted to 5 hrs time in bed/night
Secondary outcomes (8)
Insulin release (i.e., pancreatic beta cell function) measured on IVGTT
Measured: Following 3 nights of a continued 'sleep replete' period with 10 hours/night of time in bed and again following 7 days sleep restricted to 5 hrs time in bed/night
Glucose effectiveness measured using an IVGTT, clamp
Measured: Following 3 nights of a continued 'sleep replete' period with 10 hours/night of time in bed and again following 7 days sleep restricted to 5 hrs time in bed/night
Biomarkers of Sleep Loss (HbA1c, fructosamine, insulin, glucose, cortisol thyrotropic axis function, lipid metabolism, leptin, ghrelin and cytokine signaling)
Measured: Following 3 nights of a continued 'sleep replete' period with 10 hours/night of time in bed and again following 7 days sleep restricted to 5 hrs time in bed/night
Subjective measures of sleepiness and alertness
Measured: Every 3 hours while awake during the 12-day inpatient stay
RMR assessed by indirect calorimetry
Measured: On the morning and late afternoon of day 4 and 11
Urinary catecholamines levels
Measured: Over 24 hours on days 3, 4, 10, 11
Salivary free cortisol
Measured: Every 30 minutes in the afternoon of days 3, 4, 10, 11
Neurobehavioral performance
Measured: approx very 3 hours during wake in the 12-day inpatient stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startJan 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep RestrictionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Orfeu M Buxton, Ph.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895570
- Sponsor's protocol ID
- C1538/6032/ES/US
- Status last verified
- May 2009
- First submitted
- 6 May 2009
- Last updated
- 8 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Buxton OM, Pavlova M, Reid EW, Wang W, Simonson DC, Adler GK. Sleep restriction for 1 week reduces insulin sensitivity in healthy men. Diabetes. 2010 Sep;59(9):2126-33. doi: 10.2337/db09-0699. Epub 2010 Jun 28.
PubMed 20585000
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Restriction, Impaired Glucose Metabolism, and Performance: The Effects of Modafinil to Counteract the Adverse Metabolic Consequences of Sleep Restriction
- ClinicalTrials.gov ID
- NCT00895570
- Acronym / sponsor ID
- C1538/6032/ES/US
- Conditions
- Sleep Restriction, Impaired Glucose Metabolism
- Keywords
- sleep restriction, glucose metabolism, modafinil, euglycemic clamp, insulin sensitivity, insulin release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 8 May 2009 (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.
The purpose of the study is to examine the effects of sleep and modafinil on how the body processes glucose.
Detailed description
The occurrence and diagnosis of DM2 and its complications is increasing, leading to rising treatment costs that represent a considerable portion of the U.S. health care budget. Although treatment of impaired glucose tolerance (IGT) is not common, an IGT diagnosis increases the likelihood of progression to DM2. Careful attention to glycemic control is a primary treatment goal for DM2 patients, as glucose control reduces the severity of microvascular, macrovascular, and other complications.
Recent research has indicated that sleep loss could be a previously unrecognized risk factor for DM2. As sleep restriction has become an endemic condition in developed countries, it is possible that sleep loss contributes to the recent epidemic of DM2. Protecting sleep by increasing sleep duration and quality in DM2 and IGT patients may provide an inexpensive, relatively easy to implement intervention to reduce the risk of disease onset or delay disease progression by improving glucose tolerance. Furthermore, measurement of endocrine, metabolic, and cardiovascular parameters in the proposed studies may provide insights into the mechanisms by which sleep extension improves glucose tolerance under pathophysiological conditions.
The proposed study examines and quantifies in adults the link between insufficient sleep and increased insulin resistance, impaired insulin secretion, and reduced non-insulin-dependent glucose utilization by the sleepy brain. The proposed study capitalizes upon the unique pharmacological characteristics of modafinil to reverse excessive sleepiness to address the mechanisms by which sleep restriction may impact metabolism via excessive sleepiness. This study may lead to countermeasures to the adverse health impact of chronic insufficient sleep, an increasingly common lifestyle that may ultimately contribute to the development of the Metabolic Syndrome or DM2 via alterations of glucose metabolism and brain glucose utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modafinil | Experimental | Drug: modafinilDuring each day of the 7-day sleep restriction phase of the study modafinil was administered (200 mg tablet at 0600, and a second dose of 100 mg tablet at 1300). |
| Placebo | Placebo comparator | Drug: placeboDuring each day of the 7-day sleep restriction phase of the study a sugar pill was administered. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects must have also demonstrated a full understanding of the requirements and demands of the study.
- Individuals must have been willing to follow a regular sleep-wake schedule.
Key exclusion criteria (5 listed)
- Sleep/wake history. During completion of the preliminary telephone and written screening questionnaires, potential volunteers were asked a number of questions about their present, past and desired habitual sleep/wake schedule, including their habitual and desired bedtimes, wake-times, and nap times. Those potential volunteers with a history of night-work in the preceding 3-year period or travel across >2 time zones in the 3 months prior to the study were excluded.
- Individuals who are unable or unwilling to follow a regular sleep-wake schedule were excluded from the study.
- Drug/Alcohol Use. Volunteers must have been drug-free (including nicotine) and with moderate or no use of caffeine or alcohol for the entire duration of the study. No medications (prescription or over the counter) that significantly affect circadian rhythms, endocrine physiology, or sleep were allowed. They must have had no history of drug or alcohol dependency. No caffeine or alcohol were allowed for one week prior to or during the inpatient portion of the protocol. A comprehensive toxicological analysis of blood and urine for prescription medication, non-prescription medication, drugs of abuse, and caffeine, nicotine and alcohol metabolites was carried out for verification of reported non-use during the initial screening and on the day of admission to the laboratory for verification.
- Evaluation of Medical Suitability. Only healthy, non-obese men were selected for this study. Subjects must have been free from any acute, chronic or debilitating medical conditions. Normality was established on the basis of clinical history, electrocardiogram, clinical biochemical screening tests of blood and urine, and a physical examination conducted by a licensed physician. Any subject with symptoms of active illness (e.g., fever, leukocytosis, hypertension) was excluded from study. Given the wide range of illnesses that are encountered in medical practice, it would not be possible to provide a comprehensive list of each and every disease that could serve as grounds for exclusion for the subject. However, the following is a list of illnesses that would certainly have been grounds for exclusion: Chronobiologic Disorders, Sleep Disorders, Diseases of the Cardiovascular System, Disorders of the Kidney and Urinary Tract, Infectious Diseases, Disorders of the Gastrointestinal System, Disorders of the Immune System, Connective Tissue and Joints, Disorders of the Hematopoietic System, Neoplastic Diseases, Endocrine and Metabolic Diseases, Neurologic Disorders; significant impairments of the visual system.
- Evaluation of Psychiatric/Psychological Suitability. Each potential volunteer completed a series of psychological questionnaires received a comprehensive psychological examination by a clinical psychologist experienced with the psychological screening for the subjects in our studies. Individuals with evidence of psychopathology on standardized questionnaires or in a structured interview were excluded from study. Individuals with a history of psychiatric illnesses or psychiatric disorders were excluded. Individuals who are unaware of specific psychiatric diagnoses who have a history of having been treated with antidepressant, neuroleptic medications or major tranquilizers were excluded from study. However, a personal history of limited prior counseling or psychotherapy (e.g., for adjustment reactions) was not necessarily exclusionary. Potential subjects were evaluated for Axis II personality types that might interfere with protocol compliance or with their personal ability to tolerate the conditions of the study, such as temporal isolation and confinement.
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 |
|---|---|---|
| modafinilAlso: ProvigilDuring each day of the 7-day sleep restriction phase of the study modafinil was administered (200 mg tablet at 0600, and a second dose of 100 mg tablet at 1300). | Drug | Modafinil |
| placeboDuring each day of the 7-day sleep restriction phase of the study a sugar pill was administered. | Drug | Placebo |
Primary outcome
Insulin sensitivity measured with euglycemic hyperinsulinemic clamp
Time frame: Following 3 nights of a continued 'sleep replete' period with 10 hours/night of time in bed and again following 7 days sleep restricted to 5 hrs time in bed/night
8 secondary outcomes
Insulin release (i.e., pancreatic beta cell function) measured on IVGTT
Time frame: Following 3 nights of a continued 'sleep replete' period with 10 hours/night of time in bed and again following 7 days sleep restricted to 5 hrs time in bed/night
Glucose effectiveness measured using an IVGTT, clamp
Time frame: Following 3 nights of a continued 'sleep replete' period with 10 hours/night of time in bed and again following 7 days sleep restricted to 5 hrs time in bed/night
Biomarkers of Sleep Loss (HbA1c, fructosamine, insulin, glucose, cortisol thyrotropic axis function, lipid metabolism, leptin, ghrelin and cytokine signaling)
Time frame: Following 3 nights of a continued 'sleep replete' period with 10 hours/night of time in bed and again following 7 days sleep restricted to 5 hrs time in bed/night
Subjective measures of sleepiness and alertness
Time frame: Every 3 hours while awake during the 12-day inpatient stay
RMR assessed by indirect calorimetry
Time frame: On the morning and late afternoon of day 4 and 11
Urinary catecholamines levels
Time frame: Over 24 hours on days 3, 4, 10, 11
Salivary free cortisol
Time frame: Every 30 minutes in the afternoon of days 3, 4, 10, 11
Neurobehavioral performance
Time frame: approx very 3 hours during wake in the 12-day inpatient stay
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 8 May 2009.
- Derived from this study: PubMed 20585000Buxton OM, Pavlova M, Reid EW, Wang W, Simonson DC, Adler GK. Sleep restriction for 1 week reduces insulin sensitivity in healthy men. Diabetes. 2010 Sep;59(9):2126-33. doi: 10.2337/db09-0699. Epub 2010 Jun 28.
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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.
Orfeu M Buxton, Ph.D. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modafinil in people with Sleep Restriction and Impaired Glucose Metabolism, run by Brigham and Women's Hospital 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 2 inclusion and 5 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 8 May 2009. 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. Some participants in this study may receive a placebo. 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?
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?
Insulin sensitivity measured with euglycemic hyperinsulinemic clamp (time frame: Following 3 nights of a continued 'sleep replete' period with 10 hours/night of time in bed and again following 7 days sleep restricted to 5 hrs time in bed/night). 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 NCT00895570, 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 8 May 2009.