Obstructive Sleep ApneaNCT06512285
Identification of Oxygen Desaturation in Patients Admitted Following Adenotonsillectomy'
An observational study of Obstructive Sleep Apnea, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Sleep apnea has become exceedingly recognized in children. The primary treatment for sleep apnea in children is surgery in the form of adenotonsillectomy. The majority of children that undergo adenotonsillectomy are discharged following their immediate recovery in the post anesthesia care unit. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Continuous Pulse Oximetry
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2024to 27 May 2025
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing adenotonsilectomy at Texas Children's Hospital Main campus that meet institutional requirements for post-operative admission for continuous pulse oximetry monitoring
Who may be able to join
- Adenotonsillectomy surgery
- Patient meeting institutional guidelines for postoperative admission (e.g, admitted following surgery from recovery room).
Who cannot join
- Parental refusal
- Airway Surgery in addition to adenotonsillectomy
- Patient psychological limitations, precluding wearing device (e.g. autism).
- Patient not meeting institutional guidelines for postoperative admission (e.g, discharged following surgery from recovery room).
Trial locations and contacts
1 site in 1 country.
About this study
Sleep apnea has become exceedingly recognized in children. The primary treatment for sleep apnea in children is surgery in the form of adenotonsillectomy. The majority of children that undergo adenotonsillectomy are discharged following their immediate recovery in the post anesthesia care unit.
Read the detailed description
Based on national and international consensus statements, institutional practice has developed at Texas Children's Hospital as to which patients require overnight observation following adenotonsillectomy for continuous pulse oximeter monitoring to assess for desaturation events. There is insufficient evidence to suggest which patients need to stay for pulse oximeter monitoring which has led to many patients being admitted unnecessarily. Therefore, the aim of this study is to capture data prospectively on pulse oximetry in children admitted overnight following adenotonsillectomy to identify risk factors for post operative oxygen desaturation.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Continuous Pulse Oximetry
- 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.
Continuous Pulse OximetryDiagnostic test
The patient will wear a continuous pulse oximeter after their adenotonsillectomy surgery until the following morning. This will record continuous pulse oximetry data to allow for analysis of any desaturations in the first night following the surgery. This study is observational only and this data will not be used to impact any treatment
| Study group | Role | What they receive |
|---|---|---|
| Adenotonsillectomy patients | Patients having undergone adenotonsillectomy at Texas Children's Hospital admitted for overnight observation based on our institutional protocol will be enrolled. A Wrist OX 3150 (Nonin Medical) will be placed in PACU with saturations recorded until the following morning after the surgery. The patient will undergo pulse oximetry monitoring separately based on the hospital protocol that will be used to guide care. Data from the Wrist Ox will not be avail to the treatment team and will only be analyzed for research purposes. Receives: Diagnostic Test: Continuous Pulse Oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous pulse oximetry following adenotonsillectomy
Use of a continuous capture pulse oximeter to identify oxygen desaturations postoperatively
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 posted22 Jul 2024
- Study start25 Jul 2024
- Primary completion25 May 2025
- Study completion27 May 2025
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.
- More trials run by Baylor College of MedicineThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Adler MD, MS, FAAP, Baylor College of Medicine
- Investigators
- adam adler, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512285
- Sponsor's protocol ID
- H-53724
- Status last verified
- Oct 2025
- First submitted
- 16 Jul 2024
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified data will be shared on reasonable written request to the PI. in accordance with institutional policies
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Oxygen Desaturation in Patients Admitted Following Adenotonsillectomy'
- ClinicalTrials.gov ID
- NCT06512285
- Acronym / sponsor ID
- H-53724
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 22 Jul 2024 (actual)
- 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.
Sleep apnea has become exceedingly recognized in children. The primary treatment for sleep apnea in children is surgery in the form of adenotonsillectomy. The majority of children that undergo adenotonsillectomy are discharged following their immediate recovery in the post anesthesia care unit.
Detailed description
Based on national and international consensus statements, institutional practice has developed at Texas Children's Hospital as to which patients require overnight observation following adenotonsillectomy for continuous pulse oximeter monitoring to assess for desaturation events. There is insufficient evidence to suggest which patients need to stay for pulse oximeter monitoring which has led to many patients being admitted unnecessarily. Therefore, the aim of this study is to capture data prospectively on pulse oximetry in children admitted overnight following adenotonsillectomy to identify risk factors for post operative oxygen desaturation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adenotonsillectomy patients | – | Diagnostic Test: Continuous Pulse OximetryPatients having undergone adenotonsillectomy at Texas Children's Hospital admitted for overnight observation based on our institutional protocol will be enrolled. A Wrist OX 3150 (Nonin Medical) will be placed in PACU with saturations recorded until the following morning after the surgery. The patient will undergo pulse oximetry monitoring separately based on the hospital protocol that will be used to guide care. Data from the Wrist Ox will not be avail to the treatment team and will only be analyzed for research purposes. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing adenotonsilectomy at Texas Children's Hospital Main campus that meet institutional requirements for post-operative admission for continuous pulse oximetry monitoring
Key inclusion criteria (2 listed)
- Adenotonsillectomy surgery
- Patient meeting institutional guidelines for postoperative admission (e.g, admitted following surgery from recovery room).
Key exclusion criteria (4 listed)
- Parental refusal
- Airway Surgery in addition to adenotonsillectomy
- Patient psychological limitations, precluding wearing device (e.g. autism).
- Patient not meeting institutional guidelines for postoperative admission (e.g, discharged following surgery from recovery room).
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 Pulse OximetryThe patient will wear a continuous pulse oximeter after their adenotonsillectomy surgery until the following morning. This will record continuous pulse oximetry data to allow for analysis of any desaturations in the first night following the surgery. This study is observational only and this data will not be used to impact any treatment | Diagnostic test | Adenotonsillectomy patients |
Primary outcome
Continuous pulse oximetry following adenotonsillectomy
Time frame: 1 day
Use of a continuous capture pulse oximeter to identify oxygen desaturations postoperatively
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 21 Oct 2025.
- Individual participant dataSharing planned: Undecided. Deidentified data will be shared on reasonable written request to the PI. in accordance with institutional policies
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
adam adler, MD principal investigator
Baylor College of Medicine
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 Baylor College of Medicine 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 4 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 21 Oct 2025. 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?
Continuous pulse oximetry following adenotonsillectomy (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 21 Oct 2025.