Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorder, Sleep Disturbance
Conditions
Keywords
obstructive sleep apnea, home sleep apnea testing
Brief 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
Detailed 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.
Interventions
DIAGNOSTIC_TESTHome sleep apnea test
Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.
DIAGNOSTIC_TESTPSG
Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.
Sponsors
American Academy of Sleep Medicine
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Masking description
The investigators will be masked as to the order of the two sleep tests
Intervention model description
Participants will be randomized to the initial test (home sleep apnea test or polysomnography) and then complete the alternate test within approximately one week.
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG | up to one month | Correlation will be assessed in all participants completing PSG and HSAT using the OAHI from both tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between OAHI from HSAT and score from OSA questionnaires | up to one month | 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. |
| Parent-reported preference between HSAT and PSG | up to one month | 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. |
| Child-reported preference between HSAT and PSG | up to one month | 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. |
| Parent-reported acceptability of HSAT | up to one month. | 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. |
Countries
United States
Outcome results
None listed