Lung DiseasesCATNAPNCT00089752
Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea
A study testing Continuous Positive Airway Pressure (CPAP) Treatment in people with Lung Diseases and Sleep Apnea Syndromes, run by University of Pennsylvania at 5 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether functional status improves in individuals with milder obstructive sleep apnea (OSA) following continuous positive airway pressure (CPAP) treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lung Diseases, Sleep Apnea Syndromes, Hypertension
- What is being tested?
- Continuous Positive Airway Pressure (CPAP) Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 281 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2003to Nov 2008
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with OSA on overnight polysomnogram (PSG) with RDI between 5 and 30
- Score of greater than 11 on the Epworth Sleepiness Scale (ESS) on two administrations of the instrument (performed at prescreening and screening), each completed on a different day to avoid sporadic values and confirm the presence of excessive daytime sleepiness
- Stable medical history and no change in medications, including hypertension medications, in the 3 months prior to study entry
- Stable psychiatric history and no change in psychotropic medications in the 3 months prior to study entry
- Has access to a telephone
Who cannot join
- Diagnosis of another sleep disorder in addition to OSA based on PSG, e.g., periodic limb movement disorder (greater than 10 limb movements per hour of sleep with arousal); central sleep apnea (greater than 5 or more central apneas); insomnia; sleep hypoventilation syndrome; or narcolepsy
- Previous treatment for sleep apnea with nasal CPAP, oral appliance, home oxygen therapy, uvulopalatopharyngoplasty, tracheotomy, or other surgery for OSA
- Oxygen or bi-level CPAP required for treatment of OSA
- Unable to return for study instructions or follow-up testing
- Medically unstable condition (e.g., heart attack, congestive heart failure, Cheyne-Stokes breathing, unstable angina, uncontrolled thyroid disease, unstable diabetes, depression or psychosis, ventricular arrhythmias, cirrhosis, or recently diagnosed cancer) in the 3 months prior to study entry
- Regular use (greater than 3 times per week) of sedative, hypnotic, or alerting medications (such as Modafinil) in the 3 months prior to study entry
Show all 15Show fewer
- Chronic nasal congestion that would prevent the use of a nasal mask, in the 3 months prior to study entry
- History of automobile accidents due to excessive daytime sleepiness
- Employed in transportation-related safety sensitive occupation such as an airline pilot, truck driver, or train engineer
- Night shift worker regularly experiencing jet lag, or a history of irregular work schedules in the 6 months prior to study entry
- Regular use of alcohol as determined by answering yes to one or more of the questions on the CAGE questionnaire (i.e., alcohol dependent)
- Recent or recurring history of substance abuse leading to tolerance or dependence
- Pregnant; women must either be postmenopausal or confirmed not pregnant by a urine pregnancy test
- Unable to perform study tests, e.g., inability to communicate verbally; inability to write and read in English; less than a 5th grade reading level (evaluated using Flesch-Kincaid assessment); visual impairment; hearing impairment; cognitive impairment (e.g., previous head injury); or upper extremity motor deficit (e.g., previous stroke or spinal cord injury)
- Residing with an individual who is currently using CPAP treatment
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Emory University School of Medicine (EMO)
Atlanta, Georgia, 30329
National Jewish Medical and Research Center (NJC)
Denver, Colorado, 80206
North Shore-Long Island Jewish Health System (LIJ)
Long Island City, New York, 11040
New York University Medical School
New York, New York, 10016
About this study
Official title: Impact of CPAP on Functional Outcomes in Milder Obstructive Sleep Apnea (CATNAP)
The purpose of this study is to determine whether functional status improves in individuals with milder obstructive sleep apnea (OSA) following continuous positive airway pressure (CPAP) treatment.
Read the detailed description
BACKGROUND:
OSA is characterized as mild, moderate, or severe, according to the number of respiratory disturbances per hour of sleep (RDI), as defined by the American Academy of Sleep Medicine. CPAP is the primary treatment for sleep apnea. The column of pressure delivered to the upper airway by this device immediately eliminates the respiratory disturbances when it is applied. There is evidence from randomized controlled studies that CPAP also improves functional status, and the key manifestation of OSA, including excessive daytime sleepiness, in individuals with severe OSI (i.e., RDI greater than 30). However, there has been limited research exploring improvement in functional status in individuals with less severe OSA (i.e., those with mild OSA and RDI of 5-15 or moderate OSA and RDI of 16-30). The large placebo effect that has been reported in controlled studies of OSA-associated functional outcomes mandates the need for a placebo in studies evaluating the true impact of this treatment. Results from the three randomized controlled studies in milder OSA that have examined this issue have been equivocal, principally because of serious methodological limitations. It remains unclear whether CPAP treatment improves daily functioning in those with milder OSA (RDI 5-30). This is a critical issue as this level of disease severity represents the largest segment of OSA and comprises 15% of the U.S. population.
DESIGN NARRATIVE:
Using Granger's model of functional assessment, this study will examine whether functional status improves in participants with milder OSA following CPAP treatment. The study will employ a randomized, placebo-controlled, parallel study design, and will use a sham CPAP device as the placebo in participants with significant daytime sleepiness. The study will test the hypothesis that the change in functional status (measured by the Functional Outcomes of Sleep Questionnaire) after 8 weeks of treatment will be greater for participants treated with active CPAP compared to the placebo. Secondary aims of the study include examining whether CPAP also improves daytime sleepiness, and determining whether CPAP can reduce nocturnal blood pressure to lower the risk for stroke and hypertension linked to OSA.
- Conditions
- Lung Diseases, Sleep Apnea Syndromes, Hypertension
- Being tested
- Continuous Positive Airway Pressure (CPAP) Treatment, Sham CPAP device - CPAP device with pressure delivered <1 cm H20
- Medical subject headings
- Lung Diseases, Sleep Apnea Syndromes, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP) TreatmentDevice
Also called Positive Airway Pressure
CPAP device used at night
Sham CPAP device - CPAP device with pressure delivered <1 cm H20Device
Sham CPAP device used at night
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | Continuous Positive Airway Pressure Treatment Receives: Device: Continuous Positive Airway Pressure (CPAP) Treatment |
| Sham/Placebo Treatment | Placebo comparator | Ineffective sham continuous positive airway pressure device with leak in interface to <1.0 cm H2O and resistance in motor to simulate normal operating noise and no compensation for leak. Receives: Device: Sham CPAP device - CPAP device with pressure delivered <1 cm H20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment
The primary endpoint is change after 8 weeks of treatment from baseline value (controlling for baseline value) in the 30-item Functional Outcomes of Sleep Questionnaire (FOSQ) that will be used to test the primary study hypothesis that patients with milder OSA (RDI 5-30) on active treatment will demonstrate greater mean change for the Total score from baseline to 8 weeks treatment. The FOSQ is designed to assess the impact of excessive sleepiness on functional status. The instrument has established content validity, test-retest reliability (r= 0.91), and internal consistency (alpha = 0.96). The scale ranges from 5 - 20 with normal functional status being a value greater than 17.
Measured: 8 weeks
Secondary outcomes (6)
Change in the Score From Baseline to 8 Weeks Treatment Epworth Sleepiness Scale
Change in the score from baseline to 8 weeks treatment, controlling for baseline in the self-rated 8 item measure of daytime sleepiness with a range from 0 - 24. Lower values indicting less daytime sleepiness
Measured: Measured at Baseline and Week 8 of treatment in ITT sample
Change in Mean Arterial Daytime Pressure at Baseline and Week 8 Treatment
Change in mean arterial pressure (MAP) value from baseline to 8 weeks treatment, controlling for baseline, measured by 48 hours ambulatory blood pressure device - Space Laboratories
Measured: Measured at Baseline and Week 8 treatment in the ITT sample
Change in the Score From Baseline to 8 Weeks Treatment Measured by the Profile of Mood States
Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the POMS is a reliable and valid measure of mood states that consists of 65 adjectives on which subjects' rate themselves as they feel "today" using a five-point scale. There are six mood or affective states on this test derived through factor analysis: Tension-Anxiety (score range 0-36), Depression-Dejection (score range 0 - 60), Anger-Hostility (score range 0-48), Vigor-Activity (score range 0-32), Fatigue-Inertia (score range 0-28), and Confusion-Bewilderment (score range 0-28). There is also a summary Total Mood Disturbance (TMD) score that gives a Total estimate of affective state score range 0-200). Higher scores indicate greater disability.
Measured: Measured at Baseline and Week 8 treatment in the ITT sample
Change in the Number of Lapses From Baseline to 8 Weeks Treatment on the Psychomotor Vigilance Task (PVT) - Total Lapses in 20 Minute Test
Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the PVT is an objective assessment of sleepiness and measures decrements in neurobehavioral performance due to sleepiness, i.e., ability to sustain attention and respond in a timely manner to salient signals.(7) The PVT yields five highly informative metrics on the capacity for sustained attention and vigilance performance: frequency of lapses, duration of lapse domain, optimum response time, vigilance decrement function, false response frequency. We applied this conceptually valid, relatively short duration, reliable task with known psychometric properties and minimal practice/learning curves to document attentional lapses (response times > 500 msec) in performance.
Measured: Baseline and 8 weeks of treatment in the ITT sample
Change in the Score From Baseline to 8 Weeks Treatment on the SF36 - Physical
Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the SF-36 is a 36-item questionnaire that assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate greater disability with a range of scores from 0-100.
Measured: Baseline and Week 8 of treatment in ITT sample.
Change in the Score From Baseline to 8 Weeks Treatment SF-36 Mental Component
Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the SF-36 is a 36-item questionnaire that assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate greater disability with a range of scores from 0-100.
Measured: Baseline and after 8 weeks of treatment in ITT sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2004 (estimated)
- Study startSep 2003
- Primary completionAug 2008
- Study completionNov 2008
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 (2)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Respironics Sleep and Respiratory Foundation, Cephalon
- Responsible party
- Sponsor
- Investigators
- Terri Weaver, Study chair, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089752
- Sponsor's protocol ID
- 163
- Other IDs
- R01HL076101
- Acronym
- CATNAP
- Status last verified
- Jun 2017
- First submitted
- 12 Aug 2004
- Last updated
- 24 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Petition of Principal Investigator with document outlining purpose of secondary analysis and use of the data, which is then reviewed with co-investigators for overall approval.
Publications
Weaver TE, Mancini C, Maislin G, Cater J, Staley B, Landis JR, Ferguson KA, George CF, Schulman DA, Greenberg H, Rapoport DM, Walsleben JA, Lee-Chiong T, Gurubhagavatula I, Kuna ST. Continuous positive airway pressure treatment of sleepy patients with milder obstructive sleep apnea: results of the CPAP Apnea Trial North American Program (CATNAP) randomized clinical trial. Am J Respir Crit Care Med. 2012 Oct 1;186(7):677-83. doi: 10.1164/rccm.201202-0200OC. Epub 2012 Jul 26.
PubMed 22837377Rodway GW, Weaver TE, Mancini C, Cater J, Maislin G, Staley B, Ferguson KA, George CF, Schulman DA, Greenberg H, Rapoport DM, Walsleben JA, Lee-Chiong T, Kuna ST. Evaluation of sham-CPAP as a placebo in CPAP intervention studies. Sleep. 2010 Feb;33(2):260-6. doi: 10.1093/sleep/33.2.260.
PubMed 20175410
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of CPAP on Functional Outcomes in Milder Obstructive Sleep Apnea (CATNAP)
- ClinicalTrials.gov ID
- NCT00089752
- Acronym / sponsor ID
- CATNAP / 163
- Conditions
- Lung Diseases, Sleep Apnea Syndromes, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Respironics Sleep and Respiratory Foundation, Cephalon
- Study start
- Sep 2003
- Primary completion
- Aug 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 16 Aug 2004 (estimated)
- Results
- Posted 24 Jul 2017
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 this study is to determine whether functional status improves in individuals with milder obstructive sleep apnea (OSA) following continuous positive airway pressure (CPAP) treatment.
Detailed description
BACKGROUND:
OSA is characterized as mild, moderate, or severe, according to the number of respiratory disturbances per hour of sleep (RDI), as defined by the American Academy of Sleep Medicine. CPAP is the primary treatment for sleep apnea. The column of pressure delivered to the upper airway by this device immediately eliminates the respiratory disturbances when it is applied. There is evidence from randomized controlled studies that CPAP also improves functional status, and the key manifestation of OSA, including excessive daytime sleepiness, in individuals with severe OSI (i.e., RDI greater than 30). However, there has been limited research exploring improvement in functional status in individuals with less severe OSA (i.e., those with mild OSA and RDI of 5-15 or moderate OSA and RDI of 16-30). The large placebo effect that has been reported in controlled studies of OSA-associated functional outcomes mandates the need for a placebo in studies evaluating the true impact of this treatment. Results from the three randomized controlled studies in milder OSA that have examined this issue have been equivocal, principally because of serious methodological limitations. It remains unclear whether CPAP treatment improves daily functioning in those with milder OSA (RDI 5-30). This is a critical issue as this level of disease severity represents the largest segment of OSA and comprises 15% of the U.S. population.
DESIGN NARRATIVE:
Using Granger's model of functional assessment, this study will examine whether functional status improves in participants with milder OSA following CPAP treatment. The study will employ a randomized, placebo-controlled, parallel study design, and will use a sham CPAP device as the placebo in participants with significant daytime sleepiness. The study will test the hypothesis that the change in functional status (measured by the Functional Outcomes of Sleep Questionnaire) after 8 weeks of treatment will be greater for participants treated with active CPAP compared to the placebo. Secondary aims of the study include examining whether CPAP also improves daytime sleepiness, and determining whether CPAP can reduce nocturnal blood pressure to lower the risk for stroke and hypertension linked to OSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Device: Continuous Positive Airway Pressure (CPAP) TreatmentContinuous Positive Airway Pressure Treatment |
| Sham/Placebo Treatment | Placebo comparator | Device: Sham CPAP device - CPAP device with pressure delivered <1 cm H20Ineffective sham continuous positive airway pressure device with leak in interface to <1.0 cm H2O and resistance in motor to simulate normal operating noise and no compensation for leak. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed with OSA on overnight polysomnogram (PSG) with RDI between 5 and 30
- Score of greater than 11 on the Epworth Sleepiness Scale (ESS) on two administrations of the instrument (performed at prescreening and screening), each completed on a different day to avoid sporadic values and confirm the presence of excessive daytime sleepiness
- Stable medical history and no change in medications, including hypertension medications, in the 3 months prior to study entry
- Stable psychiatric history and no change in psychotropic medications in the 3 months prior to study entry
- Has access to a telephone
Key exclusion criteria (15 listed)
- Diagnosis of another sleep disorder in addition to OSA based on PSG, e.g., periodic limb movement disorder (greater than 10 limb movements per hour of sleep with arousal); central sleep apnea (greater than 5 or more central apneas); insomnia; sleep hypoventilation syndrome; or narcolepsy
- Previous treatment for sleep apnea with nasal CPAP, oral appliance, home oxygen therapy, uvulopalatopharyngoplasty, tracheotomy, or other surgery for OSA
- Oxygen or bi-level CPAP required for treatment of OSA
- Unable to return for study instructions or follow-up testing
- Medically unstable condition (e.g., heart attack, congestive heart failure, Cheyne-Stokes breathing, unstable angina, uncontrolled thyroid disease, unstable diabetes, depression or psychosis, ventricular arrhythmias, cirrhosis, or recently diagnosed cancer) in the 3 months prior to study entry
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 |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP) TreatmentAlso: Positive Airway PressureCPAP device used at night | Device | Active Treatment |
| Sham CPAP device - CPAP device with pressure delivered <1 cm H20Sham CPAP device used at night | Device | Sham/Placebo Treatment |
Primary outcome
Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment
Time frame: 8 weeks
The primary endpoint is change after 8 weeks of treatment from baseline value (controlling for baseline value) in the 30-item Functional Outcomes of Sleep Questionnaire (FOSQ) that will be used to test the primary study hypothesis that patients with milder OSA (RDI 5-30) on active treatment will demonstrate greater mean change for the Total score from baseline to 8 weeks treatment. The FOSQ is designed to assess the impact of excessive sleepiness on functional status. The instrument has established content validity, test-retest reliability (r= 0.91), and internal consistency (alpha = 0.96). The scale ranges from 5 - 20 with normal functional status being a value greater than 17.
6 secondary outcomes
Change in the Score From Baseline to 8 Weeks Treatment Epworth Sleepiness Scale
Time frame: Measured at Baseline and Week 8 of treatment in ITT sample
Change in Mean Arterial Daytime Pressure at Baseline and Week 8 Treatment
Time frame: Measured at Baseline and Week 8 treatment in the ITT sample
Change in the Score From Baseline to 8 Weeks Treatment Measured by the Profile of Mood States
Time frame: Measured at Baseline and Week 8 treatment in the ITT sample
Change in the Number of Lapses From Baseline to 8 Weeks Treatment on the Psychomotor Vigilance Task (PVT) - Total Lapses in 20 Minute Test
Time frame: Baseline and 8 weeks of treatment in the ITT sample
Change in the Score From Baseline to 8 Weeks Treatment on the SF36 - Physical
Time frame: Baseline and Week 8 of treatment in ITT sample.
Change in the Score From Baseline to 8 Weeks Treatment SF-36 Mental Component
Time frame: Baseline and after 8 weeks of treatment in ITT sample
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22837377Weaver TE, Mancini C, Maislin G, Cater J, Staley B, Landis JR, Ferguson KA, George CF, Schulman DA, Greenberg H, Rapoport DM, Walsleben JA, Lee-Chiong T, Gurubhagavatula I, Kuna ST. Continuous positive airway pressure treatment of sleepy patients with milder obstructive sleep apnea: results of the CPAP Apnea Trial North American Program (CATNAP) randomized clinical trial. Am J Respir Crit Care Med. 2012 Oct 1;186(7):677-83. doi: 10.1164/rccm.201202-0200OC. Epub 2012 Jul 26.
- Derived from this study: PubMed 20175410Rodway GW, Weaver TE, Mancini C, Cater J, Maislin G, Staley B, Ferguson KA, George CF, Schulman DA, Greenberg H, Rapoport DM, Walsleben JA, Lee-Chiong T, Kuna ST. Evaluation of sham-CPAP as a placebo in CPAP intervention studies. Sleep. 2010 Feb;33(2):260-6. doi: 10.1093/sleep/33.2.260.
- Individual participant dataSharing planned: Yes. Petition of Principal Investigator with document outlining purpose of secondary analysis and use of the data, which is then reviewed with co-investigators for overall approval.
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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.
Terri Weaver study chair
University of Pennsylvania
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure (CPAP) Treatment in people with Lung Diseases and Sleep Apnea Syndromes, run by University of Pennsylvania at 5 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 5 inclusion and 15 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 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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?
Yes. Results are posted in the registry (first posted 24 Jul 2017). 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?
Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment (time frame: 8 weeks). 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 NCT00089752, which also lists 2 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 24 Jul 2017.