Sleep ApneaNCT01914198
Revisiting Parental Survey for Screening for Obstructive Sleep Apnea in Patients Undergoing Polysomnography
An observational study of Sleep Apnea, run by Vidya Raman at 1 site in United States.
Trial summary
The investigators are proposing a study where the investigators would give a survey to the parents of patients having a sleep study. The survey would contain questions relating to symptoms of sleep apnea and then the investigators would correlate the parent answers to the results of the sleep study. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Sleep apnea symptom survey
- How many people
- 948 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 13 Sep 2016
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who are having a sleep study at NCH.
Who may be able to join
- Any patient coming for sleep study at Nationwide Children's Hospital and parent willing to fill out questionnaire.
- Children ages 3-18 years old regardless of sex or race.
Who cannot join
- Parental refusal.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
The investigators are proposing a study where the investigators would give a survey to the parents of patients having a sleep study. The survey would contain questions relating to symptoms of sleep apnea and then the investigators would correlate the parent answers to the results of the sleep study.
- Conditions
- Sleep Apnea
- Being tested
- Sleep apnea symptom survey
- Keywords
- sleep study, NCH
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep apnea symptom surveyOther
Parents or caregivers will complete a questionnaire regarding possible sleep apnea symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Sleep study | Patients who are having a sleep study done at NCH to diagnose sleep apnea. Receives: Other: Sleep apnea symptom survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep apnea symptoms
Parents or caregivers will be asked to complete a questionnaire regarding possible symptoms related to sleep apnea.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startAug 2013
- Primary completion13 Sep 2016
- Study completion13 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 948 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidya Raman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vidya Raman, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914198
- Sponsor's protocol ID
- IRB13-00338
- Status last verified
- Jan 2018
- First submitted
- 31 Jul 2013
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revisiting Parental Survey for Screening for Obstructive Sleep Apnea in Patients Undergoing Polysomnography
- ClinicalTrials.gov ID
- NCT01914198
- Acronym / sponsor ID
- IRB13-00338
- Conditions
- Sleep Apnea
- Keywords
- sleep study, NCH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 948 participants (actual)
- Lead sponsor
- Vidya RamanUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- 13 Sep 2016 (actual)
- Study completion
- 13 Sep 2016 (actual)
- First posted
- 2 Aug 2013 (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 investigators are proposing a study where the investigators would give a survey to the parents of patients having a sleep study. The survey would contain questions relating to symptoms of sleep apnea and then the investigators would correlate the parent answers to the results of the sleep study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep study | – | Other: Sleep apnea symptom surveyPatients who are having a sleep study done at NCH to diagnose sleep apnea. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who are having a sleep study at NCH.
Key inclusion criteria (2 listed)
- Any patient coming for sleep study at Nationwide Children's Hospital and parent willing to fill out questionnaire.
- Children ages 3-18 years old regardless of sex or race.
Key exclusion criteria (1 listed)
- Parental refusal.
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 |
|---|---|---|
| Sleep apnea symptom surveyParents or caregivers will complete a questionnaire regarding possible sleep apnea symptoms. | Other | Sleep study |
Primary outcome
Sleep apnea symptoms
Time frame: 1 Day
Parents or caregivers will be asked to complete a questionnaire regarding possible symptoms related to sleep apnea.
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 5 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sleep Apnea, run by Vidya Raman 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 2 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 5 Jan 2018. 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?
Sleep apnea symptoms (time frame: 1 Day). 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 5 Jan 2018.