Nonrestorative SleepNCT00705601
Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study
An observational study of Nonrestorative Sleep, run by Pfizer at 13 sites in 2 countries.
Trial summary
To begin to refine development of the RSQ (Restorative Sleep Questionnaire) measure in subjects with NRS (Nonrestorative Sleep) by generating item content pertaining to morning refreshment and uncovering problems in instrument administration in subjects with nonrestorative sleep Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Nonrestorative Sleep
- What is being tested?
- PSG
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Aug 2008to Jan 2009
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who self report nonrestorative sleep but no problems either getting to sleep or staying asleep
- Complaints of significant distress or impairment in social, occupational, or other important areas of functioning during daytime for at least 3 nights per week
- Self reports sWASO (Wake after sleep onset) for <45 minutes for past 3 months, self reports LPS (latency to persistent sleep onset ) for <20 minutes for past 3 months (then neither PSG (polysomnography) screening night showing WASO >45min, or LPS > 20 minutes)
- Customary bedtime betw. 9 pm and midnight and rise between 4 and 9 AM
Who cannot join
- Psychiatric disease or disorder as determined by current administration of the MINI (Mini International Neuropsychiatric Interview)
- History or presence of any breathing-related sleep disorder, narcolepsy, or any other dyssomnias or any parasomnia, or restless legs syndrome MAP > 0.5 at screening
- History or presence of any medical or neurological condition that could interfere with sleep (chronic pain, Restless leg, etc)
- Current use of meds wth known psychotropic effects or known or suspected effects on sleep
- Alcohol or substance abuse (unless in remission for at least a year
- Excessive caffeine use (or any use after 6 pm for at least 3 months
Show all 10Show fewer
- Regular napping or any naps after 6 pm
- Excessive cigarette or cigar smoking over the last 3 months
- no participation in an investigational new drug study within 30 days of screening, and no previous participation in a study of PD200390
- No night or rotating shift work
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States11 sites
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Columbus, Ohio, 43213
Pfizer Investigational Site
Crestview Hills, Kentucky, 41017
Pfizer Investigational Site
Fountain Valley, California, 92708
Pfizer Investigational Site
Louisville, Kentucky, 40217
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Pasadena, California, 91106
Pfizer Investigational Site
Pembroke Pines, Florida, 33026
Pfizer Investigational Site
San Diego, California, 92121
Pfizer Investigational Site
Tustin, California, 92780
Canada2 sites
Pfizer Investigational Site
Mississauga, Ontario, L5B 4M4
Pfizer Investigational Site
Toronto, Ontario, M6J 3S3
About this study
Official title: Refinement Of Patient Reported Outcomes Instruments In Subjects With Insomnia Characterized By Nonrestorative Sleep
To begin to refine development of the RSQ (Restorative Sleep Questionnaire) measure in subjects with NRS (Nonrestorative Sleep) by generating item content pertaining to morning refreshment and uncovering problems in instrument administration in subjects with nonrestorative sleep
Read the detailed description
Study was terminated on January 20, 2009 due to portfolio decision by Pfizer to discontinue further investigation of PD200390 for non-restorative sleep. The decision was not based on any safety concerns.
- Conditions
- Nonrestorative Sleep
- Being tested
- PSG
- Keywords
- Nonrestorative Sleep, Restorative Sleep Questionnaire Refinement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSGProcedure or surgery
PSG (polysomnography) for adaptation night, day 2 evening, and day 3 evening--used to identify suitable Nonrestorative Sleep candidates to participate in focus groups.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Procedure: PSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Once subjects identified, a series of focus group sessions will be held to identify concepts, themes and items relevant to Nonrestorative Sleep.
Measured: monthly
To begin to refine the development of the RSQ measure in subjects with Nonrestorative Sleep by generating item content pertaining to morning refreshment and uncovering problems in instrument administration in subjects with nonrestorative sleep.
Measured: nightly
Identification of subjects with insomnia characterized by Nonrestorative Sleep only [assessed via LPS (latency to persistent sleep onset) and WASO (Wake after sleep onset) as determined by PSG (polysomnography)].
Measured: nightly
Secondary outcomes (3)
Subjective measures include MAF (multidimensional assessment of fatigue), Sheehan Disability Scale, SF36v2, Endicott Work productivity scale (EWPS) Global impression of severity (CGIS) and the Profile of mood states.
Measured: nightly
Secondary assessments to characterize the functional impact of insomnia including Nonrestorative Sleep include additional PSG (polysomnography) variables.
Measured: nightly
After phase IIa of this study, a questionaire to be designed - Participants to be debriefed, and interviewed to assess the content validity of the questionnaire.
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: See Detailed Description
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 Nonrestorative SleepStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705601
- Sponsor's protocol ID
- A9001380
- Status last verified
- Feb 2019
- First submitted
- 24 Jun 2008
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Drake CL, Hays RD, Morlock R, Wang F, Shikiar R, Frank L, Downey R, Roth T. Development and evaluation of a measure to assess restorative sleep. J Clin Sleep Med. 2014 Jul 15;10(7):733-41, 741A-741E. doi: 10.5664/jcsm.3860.
PubMed 25024650
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refinement Of Patient Reported Outcomes Instruments In Subjects With Insomnia Characterized By Nonrestorative Sleep
- ClinicalTrials.gov ID
- NCT00705601
- Acronym / sponsor ID
- A9001380
- Conditions
- Nonrestorative Sleep
- Keywords
- Nonrestorative Sleep, Restorative Sleep Questionnaire Refinement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: See Detailed Description
- Enrolment
- 64 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 26 Jun 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.
To begin to refine development of the RSQ (Restorative Sleep Questionnaire) measure in subjects with NRS (Nonrestorative Sleep) by generating item content pertaining to morning refreshment and uncovering problems in instrument administration in subjects with nonrestorative sleep
Detailed description
Study was terminated on January 20, 2009 due to portfolio decision by Pfizer to discontinue further investigation of PD200390 for non-restorative sleep. The decision was not based on any safety concerns.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: PSG |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects who self report nonrestorative sleep but no problems either getting to sleep or staying asleep
- Complaints of significant distress or impairment in social, occupational, or other important areas of functioning during daytime for at least 3 nights per week
- Self reports sWASO (Wake after sleep onset) for <45 minutes for past 3 months, self reports LPS (latency to persistent sleep onset ) for <20 minutes for past 3 months (then neither PSG (polysomnography) screening night showing WASO >45min, or LPS > 20 minutes)
- Customary bedtime betw. 9 pm and midnight and rise between 4 and 9 AM
Key exclusion criteria (10 listed)
- Psychiatric disease or disorder as determined by current administration of the MINI (Mini International Neuropsychiatric Interview)
- History or presence of any breathing-related sleep disorder, narcolepsy, or any other dyssomnias or any parasomnia, or restless legs syndrome MAP > 0.5 at screening
- History or presence of any medical or neurological condition that could interfere with sleep (chronic pain, Restless leg, etc)
- Current use of meds wth known psychotropic effects or known or suspected effects on sleep
- Alcohol or substance abuse (unless in remission for at least a year
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 |
|---|---|---|
| PSGPSG (polysomnography) for adaptation night, day 2 evening, and day 3 evening--used to identify suitable Nonrestorative Sleep candidates to participate in focus groups. | Procedure or surgery | 1 |
Primary outcome
Once subjects identified, a series of focus group sessions will be held to identify concepts, themes and items relevant to Nonrestorative Sleep.
Time frame: monthly
To begin to refine the development of the RSQ measure in subjects with Nonrestorative Sleep by generating item content pertaining to morning refreshment and uncovering problems in instrument administration in subjects with nonrestorative sleep.
Time frame: nightly
Identification of subjects with insomnia characterized by Nonrestorative Sleep only [assessed via LPS (latency to persistent sleep onset) and WASO (Wake after sleep onset) as determined by PSG (polysomnography)].
Time frame: nightly
3 secondary outcomes
Subjective measures include MAF (multidimensional assessment of fatigue), Sheehan Disability Scale, SF36v2, Endicott Work productivity scale (EWPS) Global impression of severity (CGIS) and the Profile of mood states.
Time frame: nightly
Secondary assessments to characterize the functional impact of insomnia including Nonrestorative Sleep include additional PSG (polysomnography) variables.
Time frame: nightly
After phase IIa of this study, a questionaire to be designed - Participants to be debriefed, and interviewed to assess the content validity of the questionnaire.
Time frame: monthly
Results and safety
The study was stopped early (reason given: See Detailed Description). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Derived from this study: PubMed 25024650Drake CL, Hays RD, Morlock R, Wang F, Shikiar R, Frank L, Downey R, Roth T. Development and evaluation of a measure to assess restorative sleep. J Clin Sleep Med. 2014 Jul 15;10(7):733-41, 741A-741E. doi: 10.5664/jcsm.3860.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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.
Pfizer CT.gov Call Center study director
Pfizer
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonrestorative Sleep, run by Pfizer at 13 sites in 2 countries.
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 4 inclusion and 10 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 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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 was stopped early (reason given: See Detailed Description). Results are not available in the source record.
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?
Once subjects identified, a series of focus group sessions will be held to identify concepts, themes and items relevant to Nonrestorative Sleep. (time frame: monthly). The study lists 3 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 NCT00705601, 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 4 Mar 2019.