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| Name | Class |
|---|---|
| American Academy of Sleep Medicine | OTHER |
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This clinical trial will compare the diagnostic accuracy of type II HSAT with PSG for determining OSA status following treatment with adenotonsillectomy in children
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSAT prior to clinical sleep study | Experimental | Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography |
|
| PSG first Participants will be random | Active Comparator | Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home sleep apnea test | Diagnostic Test | Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher M Cielo, DO | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19544748 | Background | Bixler EO, Vgontzas AN, Lin HM, Liao D, Calhoun S, Vela-Bueno A, Fedok F, Vlasic V, Graff G. Sleep disordered breathing in children in a general population sample: prevalence and risk factors. Sleep. 2009 Jun;32(6):731-6. doi: 10.1093/sleep/32.6.731. | |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012893 | Sleep Wake Disorders |
| D012891 | Sleep Apnea Syndromes |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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Participants will be randomized to the initial test (home sleep apnea test or polysomnography) and then complete the alternate test within approximately one week.
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The investigators will be masked as to the order of the two sleep tests
|
| PSG | Diagnostic Test | Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff. |
|
|
| up to one month |
| 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 |
| 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 |
| 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. |
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| D020920 |
| Dyssomnias |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |