InsomniaPhase 4NCT00626210
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
A Phase 4 study testing modafinil in people with Insomnia and Sleep Initiation and Maintenance Disorders, run by VA Palo Alto Health Care System at 1 site in United States.
Trial summary
Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Each of these problems is characterized by difficulty sleeping at night and excessive daytime sleepiness. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Insomnia, Sleep Initiation and Maintenance Disorders, Alzheimer Disease
- What is being tested?
- modafinil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Oct 2012
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment
- Subjective complaint of sleep disruption, unsatisfactory sleep, early morning awakening, early bedtime, or excessive daytime sleepiness. Such complaint can be made by either the potential participant or by the caregiver.
Who cannot join
- Participation in any other clinical drug trial
- Liver failure
- Believed by the investigator to be unwilling or unable to follow the protocol
- Active liver or coronary disease
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Each of these problems is characterized by difficulty sleeping at night and excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this sleepiness. The idea behind this treatment is that sleepiness that leads to napping during the day prevents a patient from being tired or sleepy enough to get good sleep at night. This study is designed to determine if the medication can "reset" participants' sleep/wake rhythm to a more normal rhythm.
- Being tested
- modafinil
- Keywords
- Mild Cognitive Impairment (MCI), Sleep, Fatigue, Memory
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Alzheimer Disease, Cognitive Dysfunction, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modafinilDrug
Also called Provigil
100-400 mg daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Modafinil | Experimental | Not described Receives: Drug: modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal Sleep Length at 1 Month
Measured: 1 month
Secondary outcomes (1)
Improvement of Daytime Alertness and Quality of Life.
Measured: ~1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 2011
- Study completionOct 2012
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 (6)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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
- Investigators
- Jamie M Zeitzer, PhD, Principal investigator, Stanford University/VAPAHCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626210
- Sponsor's protocol ID
- 8564
- Status last verified
- Oct 2019
- First submitted
- 20 Feb 2008
- Last updated
- 28 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zeitzer JM, Buckmaster CL, Parker KJ, Hauck CM, Lyons DM, Mignot E. Circadian and homeostatic regulation of hypocretin in a primate model: implications for the consolidation of wakefulness. J Neurosci. 2003 Apr 15;23(8):3555-60. doi: 10.1523/JNEUROSCI.23-08-03555.2003.
PubMed 12716965Wisor JP, Nishino S, Sora I, Uhl GH, Mignot E, Edgar DM. Dopaminergic role in stimulant-induced wakefulness. J Neurosci. 2001 Mar 1;21(5):1787-94. doi: 10.1523/JNEUROSCI.21-05-01787.2001.
PubMed 11222668Scammell TE, Estabrooke IV, McCarthy MT, Chemelli RM, Yanagisawa M, Miller MS, Saper CB. Hypothalamic arousal regions are activated during modafinil-induced wakefulness. J Neurosci. 2000 Nov 15;20(22):8620-8. doi: 10.1523/JNEUROSCI.20-22-08620.2000.
PubMed 11069971Lambe EK, Olausson P, Horst NK, Taylor JR, Aghajanian GK. Hypocretin and nicotine excite the same thalamocortical synapses in prefrontal cortex: correlation with improved attention in rat. J Neurosci. 2005 May 25;25(21):5225-9. doi: 10.1523/JNEUROSCI.0719-05.2005.
PubMed 15917462Saper CB, German DC. Hypothalamic pathology in Alzheimer's disease. Neurosci Lett. 1987 Mar 9;74(3):364-70. doi: 10.1016/0304-3940(87)90325-9.
PubMed 2436113McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
PubMed 33189083
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
- ClinicalTrials.gov ID
- NCT00626210
- Acronym / sponsor ID
- 8564
- Keywords
- Mild Cognitive Impairment (MCI), Sleep, Fatigue, Memory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Study start
- Feb 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Posted 30 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Each of these problems is characterized by difficulty sleeping at night and excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this sleepiness. The idea behind this treatment is that sleepiness that leads to napping during the day prevents a patient from being tired or sleepy enough to get good sleep at night. This study is designed to determine if the medication can "reset" participants' sleep/wake rhythm to a more normal rhythm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modafinil | Experimental | Drug: modafinil |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment
- Subjective complaint of sleep disruption, unsatisfactory sleep, early morning awakening, early bedtime, or excessive daytime sleepiness. Such complaint can be made by either the potential participant or by the caregiver.
Key exclusion criteria (4 listed)
- Participation in any other clinical drug trial
- Liver failure
- Believed by the investigator to be unwilling or unable to follow the protocol
- Active liver or coronary disease
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: Provigil100-400 mg daily for 4 weeks | Drug | Modafinil |
Primary outcome
Nocturnal Sleep Length at 1 Month
Time frame: 1 month
1 secondary outcome
Improvement of Daytime Alertness and Quality of Life.
Time frame: ~1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12716965Zeitzer JM, Buckmaster CL, Parker KJ, Hauck CM, Lyons DM, Mignot E. Circadian and homeostatic regulation of hypocretin in a primate model: implications for the consolidation of wakefulness. J Neurosci. 2003 Apr 15;23(8):3555-60. doi: 10.1523/JNEUROSCI.23-08-03555.2003.
- Background: PubMed 11222668Wisor JP, Nishino S, Sora I, Uhl GH, Mignot E, Edgar DM. Dopaminergic role in stimulant-induced wakefulness. J Neurosci. 2001 Mar 1;21(5):1787-94. doi: 10.1523/JNEUROSCI.21-05-01787.2001.
- Background: PubMed 11069971Scammell TE, Estabrooke IV, McCarthy MT, Chemelli RM, Yanagisawa M, Miller MS, Saper CB. Hypothalamic arousal regions are activated during modafinil-induced wakefulness. J Neurosci. 2000 Nov 15;20(22):8620-8. doi: 10.1523/JNEUROSCI.20-22-08620.2000.
- Background: PubMed 15917462Lambe EK, Olausson P, Horst NK, Taylor JR, Aghajanian GK. Hypocretin and nicotine excite the same thalamocortical synapses in prefrontal cortex: correlation with improved attention in rat. J Neurosci. 2005 May 25;25(21):5225-9. doi: 10.1523/JNEUROSCI.0719-05.2005.
- Background: PubMed 2436113Saper CB, German DC. Hypothalamic pathology in Alzheimer's disease. Neurosci Lett. 1987 Mar 9;74(3):364-70. doi: 10.1016/0304-3940(87)90325-9.
- Derived from this study: PubMed 33189083McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
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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.
Jamie M Zeitzer, PhD principal investigator
Stanford University/VAPAHCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing modafinil in people with Insomnia and Sleep Initiation and Maintenance Disorders, run by VA Palo Alto Health Care System 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 4 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: stopped early, as of the sponsor's last update on 28 Oct 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2014). 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?
Nocturnal Sleep Length at 1 Month (time frame: 1 month). 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 NCT00626210, which also lists 6 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 28 Oct 2019.