Obstructive Sleep ApneaNCT02044900
Polysomnography and Heart Rate Indexes in Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Ovidiu Constantin Baltatu at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the diagnostic accuracy of polysomnography indexes for diagnosis of sleep apnea in human subjects obstructive sleep apnea (OSA). This includes evaluation of polysomnography indexes (AHI; AI, arousal index; ODI, oxygen desaturation index) and heart rate variability (HRV) indexes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2012to Apr 2013
- How long will I take part?
- 1 Day
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Study population: primary care clinic
Who may be able to join
- Diagnosis of obstructive sleep apnea with an apnea-hypopnea index (AHI) > 5.
Who cannot join
- Subjects with a history or clinical examination suggestive of neuromuscular disease, hypertension or any surgical treatment were not considered in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the diagnostic accuracy of polysomnography indexes for diagnosis of sleep apnea in human subjects obstructive sleep apnea (OSA). This includes evaluation of polysomnography indexes (AHI; AI, arousal index; ODI, oxygen desaturation index) and heart rate variability (HRV) indexes.
Read the detailed description
This is a cross-sectional study collecting data from patients from the Sleep Institute of Itaperuna, Rio de Janeiro, Brazil. Polysomnography (PSG) monitoring and diagnosis was in accordance with American Society of Sleep Medicine (ASSM) standards. Standard baseline polysomnography is performed using a computerised system. The following extracted signals are measured: 2 electroencephalogram channels (O1-A2, O2-A1, C3-A2, C4-A1), 2 electrooculogram channels, electromyography (EMG, bilateral anterior tibialis), pulse oximetry (arterial oxygen saturation), nasal-oral airflow (thermistors), and electrocardiogram (ECG derivation DII). The polysomnograms are scored according to the criteria of Rechtschaffen and Kales.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, polysomnography, heart rate variability, mathematical biomarker
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography indexes
Polysomnography indexes and full-length sleep ECG recordings are extracted from polysomnogram measurements.
Measured: one night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ovidiu Constantin Baltatu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ovidiu Constantin Baltatu, Universidade Camilo Castelo Branco
- Investigators
- Ovidiu C Baltatu, MD PhD, Study chair, Camilo Castelo Branco University (UNICASTELO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044900
- Sponsor's protocol ID
- BR-001-SJC
- Other IDs
- 01328712.0.0000.5244
- Status last verified
- Jan 2014
- First submitted
- 22 Jan 2014
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polysomnography and Heart Rate Indexes in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02044900
- Acronym / sponsor ID
- BR-001-SJC
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, polysomnography, heart rate variability, mathematical biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ovidiu Constantin BaltatuUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Jan 2014 (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.
The purpose of this study is to evaluate the diagnostic accuracy of polysomnography indexes for diagnosis of sleep apnea in human subjects obstructive sleep apnea (OSA). This includes evaluation of polysomnography indexes (AHI; AI, arousal index; ODI, oxygen desaturation index) and heart rate variability (HRV) indexes.
Detailed description
This is a cross-sectional study collecting data from patients from the Sleep Institute of Itaperuna, Rio de Janeiro, Brazil. Polysomnography (PSG) monitoring and diagnosis was in accordance with American Society of Sleep Medicine (ASSM) standards. Standard baseline polysomnography is performed using a computerised system. The following extracted signals are measured: 2 electroencephalogram channels (O1-A2, O2-A1, C3-A2, C4-A1), 2 electrooculogram channels, electromyography (EMG, bilateral anterior tibialis), pulse oximetry (arterial oxygen saturation), nasal-oral airflow (thermistors), and electrocardiogram (ECG derivation DII). The polysomnograms are scored according to the criteria of Rechtschaffen and Kales.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- Diagnosis of obstructive sleep apnea with an apnea-hypopnea index (AHI) > 5.
Key exclusion criteria (1 listed)
- Subjects with a history or clinical examination suggestive of neuromuscular disease, hypertension or any surgical treatment were not considered in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Polysomnography indexes
Time frame: one night
Polysomnography indexes and full-length sleep ECG recordings are extracted from polysomnogram measurements.
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 24 Jan 2014.
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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.
Ovidiu C Baltatu, MD PhD study chair
Camilo Castelo Branco University (UNICASTELO)
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 Obstructive Sleep Apnea, run by Ovidiu Constantin Baltatu at 1 site in Brazil.
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 24 Jan 2014. 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 Brazil. 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?
Polysomnography indexes (time frame: one night). It is what the study was designed to measure, not a finding.
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 24 Jan 2014.