Obstructive Sleep ApneaNCT00811746
Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?
A study testing Rozerem (Ramelteon) and Lunesta (Eszopiclone) in people with Obstructive Sleep Apnea, run by Southern California Institute for Research and Education at 1 site in United States.
Trial summary
This study is being conducted to determine if eszopiclone is as effective as ramelteon when used as a pre-medication (sleeping pill) in sleep studies performed to diagnose and treat sleep apnea. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Rozerem (Ramelteon) and Lunesta (Eszopiclone)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Oct 2010
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred by VA Long Beach Sleep Clinic at their initial evaluation during outpatient consultation for suspect obstructive sleep apnea.
Who cannot join
- Sleep disorders other than obstructive sleep apnea
- No prior PSG
- Uncontrolled medical condition
- Prior known adverse reaction to eszopiclone or ramelteon
- Liver disfunction
- Current alcohol abuser
Show all 11Show fewer
- Current illicit drug abuser
- Alcohol consumption 12 hours prior to polysomnography
- Decompensated psychiatric disorders
- Severe dementia
- Concomitant use of benzodiazepines, trazodone, narcotics, barbiturates or other medications with sedative or hypnotic effects
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Long Beach Healthcare System
Long Beach, California, 90822-5201
About this study
This study is being conducted to determine if eszopiclone is as effective as ramelteon when used as a pre-medication (sleeping pill) in sleep studies performed to diagnose and treat sleep apnea.
Read the detailed description
Many Veterans suffer from sleep disordered breathing with a high prevalence of undiagnosed obstructive sleep apnea. One test that can be effective in the diagnosis of sleep apnea is the polysomnogram (PSG). Split-night PSG consists of a diagnostic phase in the first half of the night and a continuous positive airway pressure titration (CPAP) in the second half of the night. CPAP is the standard, most effective therapy for obstructive sleep apnea. Due to the unfamiliar sleep environment of the laboratory and instrumentation that must be used (application of electroencephalogram leads), patients are frequently not able to sleep adequately. In these cases, the PSG must be repeated. Oral hypnotic agents are often used as a pre-medication to increase the yield of PSG in an attempt to decrease the need for repeat studies.
Numerous data is available on the effects of premedication with oral short-acting hypnotics on PSG quality and efficacy of CPAP titration. In one study, eszopiclone, a nonbenzodiazepine gaba-receptor agonist short-acting hypnotic, has been shown to improve PSG quality and CPAP titration. Another short-acting hypnotic, ramelteon, was recently approved by FDA but the effects of ramelteon in improving PSG quality and efficacy of CPAP titration are unclear. The advantage of ramelteon over eszopiclone is the lack of drug dependency or abuse potential. This study aims to evaluate the efficacy of ramelteon compared to eszopiclone when administered prior to split-night PSG and CPAP titration.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Rozerem (Ramelteon), Lunesta (Eszopiclone), Historical Controls
- Keywords
- obstructive sleep apnea, eszopiclone, ramelteon, polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rozerem (Ramelteon)Drug
Also called Ramelteon
8 mg taken orally 30 minutes before a split-night PSG
Lunesta (Eszopiclone)Drug
Also called Eszopiclone
3 mg taken orally 30 minutes before the start of a split-night PSG
Historical ControlsOther
Chart review matched for demographics and comorbidities of the study drug groups.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rozerem (Ramelteon) 8 mg taken orally 30 minutes before a split-night PSG Receives: Drug: Rozerem (Ramelteon) |
| 2 | Active comparator | Lunesta (Eszopiclone) 3 mg taken 30 minutes before the start of split-night PSG Receives: Drug: Lunesta (Eszopiclone) |
| 3 | Other | Historical controls (chart review) matched for demographics and comorbidities of the study drug groups. Receives: Other: Historical Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-usable and poor quality PSGs and CPAP intolerance
Measured: The morning following the PSG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2010
- Study completionOct 2010
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 Obstructive Sleep ApneaStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern California Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine_Sassoon, Southern California Institute for Research and Education
- Investigators
- Catherine S. Sassoon, MD, Principal investigator, VA Long Beach Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811746
- Sponsor's protocol ID
- #924
- Status last verified
- May 2013
- First submitted
- 17 Dec 2008
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lettieri CJ, Quast TN, Eliasson AH, Andrada T. Eszopiclone improves overnight polysomnography and continuous positive airway pressure titration: a prospective, randomized, placebo-controlled trial. Sleep. 2008 Sep;31(9):1310-6.
PubMed 18788656
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?
- ClinicalTrials.gov ID
- NCT00811746
- Acronym / sponsor ID
- #924
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, eszopiclone, ramelteon, polysomnography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Southern California Institute for Research and EducationUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Dec 2008 (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 is being conducted to determine if eszopiclone is as effective as ramelteon when used as a pre-medication (sleeping pill) in sleep studies performed to diagnose and treat sleep apnea.
Detailed description
Many Veterans suffer from sleep disordered breathing with a high prevalence of undiagnosed obstructive sleep apnea. One test that can be effective in the diagnosis of sleep apnea is the polysomnogram (PSG). Split-night PSG consists of a diagnostic phase in the first half of the night and a continuous positive airway pressure titration (CPAP) in the second half of the night. CPAP is the standard, most effective therapy for obstructive sleep apnea. Due to the unfamiliar sleep environment of the laboratory and instrumentation that must be used (application of electroencephalogram leads), patients are frequently not able to sleep adequately. In these cases, the PSG must be repeated. Oral hypnotic agents are often used as a pre-medication to increase the yield of PSG in an attempt to decrease the need for repeat studies.
Numerous data is available on the effects of premedication with oral short-acting hypnotics on PSG quality and efficacy of CPAP titration. In one study, eszopiclone, a nonbenzodiazepine gaba-receptor agonist short-acting hypnotic, has been shown to improve PSG quality and CPAP titration. Another short-acting hypnotic, ramelteon, was recently approved by FDA but the effects of ramelteon in improving PSG quality and efficacy of CPAP titration are unclear. The advantage of ramelteon over eszopiclone is the lack of drug dependency or abuse potential. This study aims to evaluate the efficacy of ramelteon compared to eszopiclone when administered prior to split-night PSG and CPAP titration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rozerem (Ramelteon)Rozerem (Ramelteon) 8 mg taken orally 30 minutes before a split-night PSG |
| 2 | Active comparator | Drug: Lunesta (Eszopiclone)Lunesta (Eszopiclone) 3 mg taken 30 minutes before the start of split-night PSG |
| 3 | Other | Other: Historical ControlsHistorical controls (chart review) matched for demographics and comorbidities of the study drug groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referred by VA Long Beach Sleep Clinic at their initial evaluation during outpatient consultation for suspect obstructive sleep apnea.
Key exclusion criteria (11 listed)
- Sleep disorders other than obstructive sleep apnea
- No prior PSG
- Uncontrolled medical condition
- Prior known adverse reaction to eszopiclone or ramelteon
- Liver disfunction
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 |
|---|---|---|
| Rozerem (Ramelteon)Also: Ramelteon8 mg taken orally 30 minutes before a split-night PSG | Drug | 1 |
| Lunesta (Eszopiclone)Also: Eszopiclone3 mg taken orally 30 minutes before the start of a split-night PSG | Drug | 2 |
| Historical ControlsChart review matched for demographics and comorbidities of the study drug groups. | Other | 3 |
Primary outcome
Non-usable and poor quality PSGs and CPAP intolerance
Time frame: The morning following the PSG
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 May 2013.
- Background: PubMed 18788656Lettieri CJ, Quast TN, Eliasson AH, Andrada T. Eszopiclone improves overnight polysomnography and continuous positive airway pressure titration: a prospective, randomized, placebo-controlled trial. Sleep. 2008 Sep;31(9):1310-6.
- Southern California Institute for Research and Education WebsiteLink provided by the sponsor.
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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.
Catherine S. Sassoon, MD principal investigator
VA Long Beach Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rozerem (Ramelteon) and Lunesta (Eszopiclone) in people with Obstructive Sleep Apnea, run by Southern California Institute for Research and Education 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 11 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 May 2013. 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.
What does the primary outcome measure?
Non-usable and poor quality PSGs and CPAP intolerance (time frame: The morning following the PSG). 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 NCT00811746, 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 30 May 2013.