HSAT for OSA Management in Children

Sleep Apnea, Obstructive Clinical Trial

— HOM-Kids  

Official title:

Home Sleep Apnea Testing for the Evaluation of Obstructive Sleep Apnea in Children Following Management With Adenotonsillectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05516524
• Other study ID #: 22-020232
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2023
• Source: Children's Hospital of Philadelphia
• Contact: Yaelis Roman-Rosado, BS
• Phone: 215-590-9184
• Email: romanyd[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial will compare the diagnostic accuracy of type II HSAT with PSG for determining OSA status following treatment with adenotonsillectomy in children

Description:

Many children have residual obstructive sleep apnea (OSA) following adenotonsillectomy, but in-lab polysomnography (PSG), the recommended means of re-evaluating these patients, is resource-intensive and availability is limited. Home sleep apnea testing (HSAT), a similar test performed in the patient's home and used clinically in adults, may offer an alternative means of evaluating the effect of OSA treatment in children and make testing more convenient and widely available.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2027
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Male and female children age 5-12 years old inclusive

• History of adenotonsillectomy for OSA

Exclusion Criteria:

• Children with a history of hypoventilation or hypoxemia or who require supplemental oxygen or positive airway pressure during sleep

• Children with a tracheostomy or tracheocutaneous fistula

• Children who live in a facility without their parent

Related Conditions & MeSH terms

• Apnea
• Dyssomnias
• Parasomnias
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disorder
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Diagnostic Test:
• Home sleep apnea test
Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.
• PSG
Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	American Academy of Sleep Medicine

Country where clinical trial is conducted

United States, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG	Correlation will be assessed in all participants completing PSG and HSAT using the OAHI from both tests	up to one month
Secondary	Correlation between OAHI from HSAT and score from OSA questionnaires	Correlation between OAHI from HSAT will be measured by completion of the Pediatric Sleep Questionnaire-Sleep Related Breathing Disorders scale (PSQ-SRBD) and OSA-18 Questionnaire. . The PSQ-SRBD is a 22-item questionnaire where a score of >0.33 is consistent with a diagnosis of OSA. The OSA-18 consists of 18 questions for which the overall total scores will assess for OSA risk. Total scores range from 18 to 126, with 18 indicating low risk of OSA and 126 indicating high risk of OSA.	up to one month
Secondary	Parent-reported preference between HSAT and PSG	Parent-reported preference between HSAT and PSG will be measured by the parents' completion of the preference questionnaire after completion of both studies. The questionnaire contains 5 questions for which the overall score will assess for preference. Total scores range from 5 to 10, with 5 indicating a strong preference for HSAT and 10 indicating a low preference for HSAT.	up to one month
Secondary	Child-reported preference between HSAT and PSG	Child-reported preference between HSAT and PSG will be measured by the child's completion of the preference questionnaire after completion of both studies. The questionnaire contains 5 questions for which the overall score will assess for preference. Total scores range from 5 to 10, with 5 indicating a strong preference for HSAT and 10 indicating a low preference for HSAT.	up to one month
Secondary	Parent-reported acceptability of HSAT	Parent-reported acceptability of HSAT will be measures by the parents' completion of the acceptability questionnaire after completion of both studies. The questionnaire contains 4 questions for which the overall score will assess for preference. Total scores range from 4 to 20, with 4 indicating a strong preference for HSAT and 20 indicating a low preference for HSAT.	up to one month.