Primary InsomniaNCT00167375
Testing the Nocturnal Sleep Latency Profile in Primary Insomnia
An observational study of Primary Insomnia and Sleep Initiation and Maintenance Disorders, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study tests a new kind of sleep study in which subjects are awakened 2 times after initially going to sleep. The study focuses on the EEG signal process as a person goes to sleep. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Insomnia, Sleep Initiation and Maintenance Disorders
- What is being tested?
- eszopiclone 3 mg qHS and General cognitive/behavioral interventions for insomnia
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jun 2007
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primary Insomnia (N = 12) Age \& Gender matched Healthy controls (N = 12)
Who cannot join
- Unstable Medical illness No other Sleep disorder BMI > 35, AHI > 10, PLM Index > 10, Ferritin < 50. Unable to communicate in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
This study tests a new kind of sleep study in which subjects are awakened 2 times after initially going to sleep. The study focuses on the EEG signal process as a person goes to sleep. The general hypothesis is that the signal properties are stable from night to night during baseline studies, and are different between controls and patients with primary insomnia. The primary insomnia patients then go on to have about 2 weeks of an insomnia intervention. Then the new kind of study is repeated in the patients. The controls only are examined in baseline studies.
Read the detailed description
Patients are carefully screened to have DSM primary insomnia, and do not have another disorder than may cause a sleep disturbance. After a 2-week baseline period, the subjects undergo a screening sleep study to rule out sleep apnea and periodic limb movement disorder. Then they undergo the NSLP procedure. In that procedure, there pre-bedtime EEG recordings and questionnaire responses taken. Then at a planned time, the subjects go to bed and try to sleep while there EEG signals are recorded. After the first and second sleep cycles, they are awakened for one minute, then asked to return to sleep. In the morning additional recordings and questionnaire responses are obtained. Two nights later they repeat a baseline NSLP procedure. The controls then end their participation. The Patients then receive an open treatment with eszopiclone and behavioral treatments so that their insomnia may improve. After 2 weeks intervention, the patients complete one NLSP night. The goal of the study is to see if there can be data to support the idea that the sleep onset process might harbor a sign of primary insomnia that could be used for the development of a better medical model of primary insomnia.
- Being tested
- eszopiclone 3 mg qHS, General cognitive/behavioral interventions for insomnia
- Keywords
- Insomnia, polysomnography, sleep onset, time series analysis
- 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.
eszopiclone 3 mg qHSDrug
General cognitive/behavioral interventions for insomniaBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine, Sumitomo Pharma America, Inc.
- Investigators
- Douglas E Moul, M.D., M.P.H, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167375
- Sponsor's protocol ID
- NSLP1
- Other IDs
- 27-CA-04
- Status last verified
- Feb 2008
- First submitted
- 9 Sep 2005
- Last updated
- 15 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Nocturnal Sleep Latency Profile in Primary Insomnia
- ClinicalTrials.gov ID
- NCT00167375
- Acronym / sponsor ID
- NSLP1
- Keywords
- Insomnia, polysomnography, sleep onset, time series analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine, Sumitomo Pharma America, Inc.
- Study start
- Jan 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 14 Sep 2005 (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.
This study tests a new kind of sleep study in which subjects are awakened 2 times after initially going to sleep. The study focuses on the EEG signal process as a person goes to sleep. The general hypothesis is that the signal properties are stable from night to night during baseline studies, and are different between controls and patients with primary insomnia. The primary insomnia patients then go on to have about 2 weeks of an insomnia intervention. Then the new kind of study is repeated in the patients. The controls only are examined in baseline studies.
Detailed description
Patients are carefully screened to have DSM primary insomnia, and do not have another disorder than may cause a sleep disturbance. After a 2-week baseline period, the subjects undergo a screening sleep study to rule out sleep apnea and periodic limb movement disorder. Then they undergo the NSLP procedure. In that procedure, there pre-bedtime EEG recordings and questionnaire responses taken. Then at a planned time, the subjects go to bed and try to sleep while there EEG signals are recorded. After the first and second sleep cycles, they are awakened for one minute, then asked to return to sleep. In the morning additional recordings and questionnaire responses are obtained. Two nights later they repeat a baseline NSLP procedure. The controls then end their participation. The Patients then receive an open treatment with eszopiclone and behavioral treatments so that their insomnia may improve. After 2 weeks intervention, the patients complete one NLSP night. The goal of the study is to see if there can be data to support the idea that the sleep onset process might harbor a sign of primary insomnia that could be used for the development of a better medical model of primary insomnia.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Primary Insomnia (N = 12) Age \& Gender matched Healthy controls (N = 12)
Key exclusion criteria (1 listed)
- Unstable Medical illness No other Sleep disorder BMI > 35, AHI > 10, PLM Index > 10, Ferritin < 50. Unable to communicate in English
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 |
|---|---|---|
| eszopiclone 3 mg qHS | Drug | – |
| General cognitive/behavioral interventions for insomnia | Behavioural | – |
Primary outcome
Not reported in the source record.
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 15 Feb 2008.
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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.
Douglas E Moul, M.D., M.P.H principal investigator
University of Pittsburgh
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 Primary Insomnia and Sleep Initiation and Maintenance Disorders, run by University of Pittsburgh 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 1 inclusion and 1 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 15 Feb 2008. 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?
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.
Where can I read the original study information?
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 15 Feb 2008.