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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL120909 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This double-blind, randomized controlled trial will evaluate the use of nasal corticosteroids for the treatment of the childhood obstructive sleep apnea syndrome (OSAS). Efficacy, duration of action and side-effects will be determined.
Several studies have suggested that Nasal corticosteroids (NCS) or leukotriene antagonists may be effective in the treatment of childhood OSAS. However, these studies have been limited by factors such as small size, lack of randomization and blinding, short-term follow-up, involvement of children with only very mild OSAS, and/or lack of stratifying for the presence of atopy. Therefore, investigators will plan a randomized controlled trial evaluating the efficacy and safety of NCS vs placebo in children with mild to moderate OSAS. The overall hypothesis is that NCS will be safe and efficacious in the treatment of mild to moderate childhood OSAS, particularly in children with asthma/atopy, but will require ongoing maintenance therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal steroids | Active Comparator | Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone). |
|
| Placebo | Placebo Comparator | Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Fluticasone | Drug | One spray per nostril, per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Obstructive Apnea Hypopnea Index | Efficacy measure to assess acute response to nasal steroids. Obstructive apnea hypopnea index (events per hour). Per inclusion/exclusion criteria the expected range for this study at baseline is between 2 and 30 events per hour. Please note that lower and upper ranges can be broader at the 3- and 12-month points. The obstructive apnea hypopnea index (OAHI) is the sum of obstructive apneas and hypopneas, and mixed apneas divided by the total hours of sleep. Hence, the unit used is events per hour. It ranges from 0 events per hour(meaning no obstructive apneas at all) until 400 events per hour approximately. Higher values indicate more severe obstructive sleep apnea or worse outcome. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| OAHI | Efficacy measure to assess duration of response to nasal steroids. Obstructive apnea hypopnea index (events per hour). Per inclusion/exclusion criteria the expected range for this study at baseline is between 2 and 30 events per hour. Please note that lower and upper ranges can be broader at the 3- and 12-month points. | 12 months |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Carole L Marcus, MBBCh | 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 |
|---|---|---|---|
| 40051199 | Derived | Chidambaram AG, Cielo CM, Chervoneva I, Spergel JM, Tapia IE. Nasal biomarker inflammatory profile in response to intranasal corticosteroids in pediatric obstructive sleep apnea syndrome. J Clin Sleep Med. 2025 Jun 1;21(6):1033-1040. doi: 10.5664/jcsm.11604. | |
| 35779610 | Derived | Tapia IE, Shults J, Cielo CM, Kelly AB, Elden LM, Spergel JM, Bradford RM, Cornaglia MA, Sterni LM, Radcliffe J. A Trial of Intranasal Corticosteroids to Treat Childhood OSA Syndrome. Chest. 2022 Oct;162(4):899-919. doi: 10.1016/j.chest.2022.06.026. Epub 2022 Jun 30. |
| Label | URL |
|---|---|
| Related Info | View source |
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Screening: polysomnography, ophthalmologic exam, DXA scan. 75 children did not meet PSG inclusion criteria, 1 child had a coloboma, and 1 child had abnormal DXA scan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nasal Steroids | Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone). Nasal Fluticasone: One spray per nostril, per day. |
| FG001 | Placebo | Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline). Placebo: One spray per nostril, per day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nasal Steroids | Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone). Nasal Fluticasone: One spray per nostril, per day. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Obstructive Apnea Hypopnea Index | Efficacy measure to assess acute response to nasal steroids. Obstructive apnea hypopnea index (events per hour). Per inclusion/exclusion criteria the expected range for this study at baseline is between 2 and 30 events per hour. Please note that lower and upper ranges can be broader at the 3- and 12-month points. The obstructive apnea hypopnea index (OAHI) is the sum of obstructive apneas and hypopneas, and mixed apneas divided by the total hours of sleep. Hence, the unit used is events per hour. It ranges from 0 events per hour(meaning no obstructive apneas at all) until 400 events per hour approximately. Higher values indicate more severe obstructive sleep apnea or worse outcome. | Posted | Mean | 95% Confidence Interval | events per hour | 3 months |
|
Adverse events were collected monthly at telephone calls at months 2, 4, 5, 7, 8, 10 and 11, and during in-person visits at months 1, 3, 6, 9 and 12.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nasal Steroids | Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone). Nasal Fluticasone: One spray per nostril, per day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ketotic Hypoglycemia | Endocrine disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower Respiratory Tract (Including Asthma) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ignacio Tapia, MD, Principal Investigator, Associate Professor | The Children's Hospital of Philadelphia | (267) 426-5842 | tapia@chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2017 | Nov 17, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2017 | Nov 17, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Placebo | Drug | One spray per nostril, per day. |
|
|
| Nasal Obstruction Symptom Evaluation (NOSE) |
Nasal Obstruction Symptom Evaluation (NOSE) scale, a validated scale of nasal obstructive symptoms. The scales ranges from 0-100 with higher values indicating worse nasal obstruction |
| 12 months |
| The Epworth Sleepiness Scale | Epworth Sleepiness scale is a measure of sleepiness that ranges from 0-24, with higher values indicating sleepiness | 12 months |
| Pediatric Quality of Life Inventory (PedsQL) | Pediatric Quality of Life Inventory (PedsQL), a well-validated, generic measure of global quality of life, in which scores range from 0 to 100, with higher scores indicating better quality of life | 12 month |
| Behavior Rating Inventory of Executive Function (BRIEF) | Behavior Rating Inventory of Executive Function [BRIEF] Global Executive Composite T score, comprising summary measures of behavioral regulation and metacognition [with mean scores of 50 and standard deviation of 10, with higher scores indicating worse functioning] | 12 months |
| Conners Abbreviated Symptom Questionnaire | A parent-rated measure of symptoms of attention problems, yielding T scores with a mean of 50 and a standard deviation of 10 (higher scores indicate worse functioning). | 12 months |
| Purdue Peg Board | The Purdue Peg Board is a widely used test of fine motor coordination, yields z-scores with a mean of 0 and a standard deviation of 1, with higher scores indicating better performance. | 12 months |
| Conners Continuous Performance Test (CPT) | The CPT is a performance measure of sustained attention that yields T scores with a mean of 50 and a standard deviation of 10 (higher scores indicate worse functioning) | 12 months |
| Child Behavior Checklist | The Child Behavior Checklist (CBCL), is a widely used and validated caregiver-completed survey of behavior competencies that yields standardized, age-adjusted scores on internalizing, externalizing and attentional behavior difficulties81, 82. All scores are T scores with a mean of 50 and standard deviation of 10 (higher scores indicate worse functioning). | 12-Months |
Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline).
Placebo: One spray per nostril, per day.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OAHI | Obstructive apnea hypopnea index (events per hour). Per inclusion/exclusion criteria the expected range for this study at baseline is between 2 and 30 events per hour. Please note that lower and upper ranges can be broader at the 3- and 12-month points. | The total number of analyzed is different than the total number of participants is due to participants withdrawing themselves from the study or being lost to follow up. | Mean | Full Range | events per hour |
|
| Nasal Obstrction Symptoms Evaluation (NOSE) | Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated scale of nasal obstructive symptoms, modified by deleting the question about sleep and written in child-friendly language. | The total number of analyzed is different than the total number of participants is due to participants withdrawing themselves from the study or being lost to follow up. | Mean | Full Range | units on a scale |
|
| The Epworth Sleepiness Scale | Epworth Sleepiness scale is a measure of sleepiness that ranges from 0-24, with higher values indicating sleepiness | The total number of analyzed is different than the total number of participants is due to participants withdrawing themselves from the study or being lost to follow up. | Mean | Full Range | units on a scale |
|
| Pediatric Quality of Life (PedsQL) | Pediatric Quality of Life Inventory (PedsQL) is a well-validated, generic measure of global quality of life in which scores range from 0 to 100, with higher scores indicating better quality of life | The total number of analyzed is different than the total number of participants is due to participants withdrawing themselves from the study or being lost to follow up. | Mean | Full Range | units on a scale |
|
| Behavior Rating Inventory of Executive Function (BRIEF) | Behavior Rating Inventory of Executive Function [BRIEF] Global Executive Composite T score, comprising summary measures of behavioral regulation and metacognition [with mean scores of 50 and standard deviation of 10, with higher scores indicating worse functioning] | The total number of analyzed is different than the total number of participants is due to participants withdrawing themselves from the study or being lost to follow up. | Mean | Full Range | T-Score |
|
| Conners Abbreviated Symptom Questionnaire | The Conners Abbreviated Symptom Questionnaire is a parent-rated measure of symptoms of attention problems, yielding T scores with a mean of 50 and a standard deviation of 10 (higher scores indicate worse functioning). | The total number of analyzed is different than the total number of participants is due to participants withdrawing themselves from the study or being lost to follow up. | Mean | Full Range | T-Score |
|
| Conners Continuous Performance Test (CPT) | The CPT is a performance measure of sustained attention that yields T scores with a mean of 50 and a standard deviation of 10 (higher scores indicate worse functioning) | The total number of analyzed is different than the total number of participants is due to participants withdrawing themselves from the study or being lost to follow up. | Mean | Full Range | T-Score |
|
| Purdue Peg Board | The Purdue Peg Board is a widely used test of fine motor coordination, yields z-scores with a mean of 0 and a standard deviation of 1, with higher scores indicating better performance. | The total number of analyzed is different than the total number of participants is due to participants withdrawing themselves from the study or being lost to follow up. | Mean | Full Range | z-Score |
|
| OG001 | Placebo | Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline). Placebo: One spray per nostril, per day. |
|
|
| Secondary | OAHI | Efficacy measure to assess duration of response to nasal steroids. Obstructive apnea hypopnea index (events per hour). Per inclusion/exclusion criteria the expected range for this study at baseline is between 2 and 30 events per hour. Please note that lower and upper ranges can be broader at the 3- and 12-month points. | The obstructive apnea hypopnea index (OAHI) is the sum of obstructive apneas and hypopneas, and mixed apneas divided by the total hours of sleep. Hence, the unit used is events per hour. It ranges from 0 events per hour(meaning no obstructive apneas at all) until 400 events per hour approximately. Higher values indicate more severe obstructive sleep apnea or worse outcome. | Posted | Mean | 95% Confidence Interval | events per hour | 12 months |
|
|
|
| Secondary | Nasal Obstruction Symptom Evaluation (NOSE) | Nasal Obstruction Symptom Evaluation (NOSE) scale, a validated scale of nasal obstructive symptoms. The scales ranges from 0-100 with higher values indicating worse nasal obstruction | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | The Epworth Sleepiness Scale | Epworth Sleepiness scale is a measure of sleepiness that ranges from 0-24, with higher values indicating sleepiness | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | Pediatric Quality of Life Inventory (PedsQL) | Pediatric Quality of Life Inventory (PedsQL), a well-validated, generic measure of global quality of life, in which scores range from 0 to 100, with higher scores indicating better quality of life | Posted | Mean | 95% Confidence Interval | score on a scale | 12 month |
|
|
|
| Secondary | Behavior Rating Inventory of Executive Function (BRIEF) | Behavior Rating Inventory of Executive Function [BRIEF] Global Executive Composite T score, comprising summary measures of behavioral regulation and metacognition [with mean scores of 50 and standard deviation of 10, with higher scores indicating worse functioning] | Posted | Mean | 95% Confidence Interval | T-Score | 12 months |
|
|
|
| Secondary | Conners Abbreviated Symptom Questionnaire | A parent-rated measure of symptoms of attention problems, yielding T scores with a mean of 50 and a standard deviation of 10 (higher scores indicate worse functioning). | Posted | Mean | 95% Confidence Interval | T-Score | 12 months |
|
|
|
| Secondary | Purdue Peg Board | The Purdue Peg Board is a widely used test of fine motor coordination, yields z-scores with a mean of 0 and a standard deviation of 1, with higher scores indicating better performance. | Posted | Mean | 95% Confidence Interval | z-Score | 12 months |
|
|
|
| Secondary | Conners Continuous Performance Test (CPT) | The CPT is a performance measure of sustained attention that yields T scores with a mean of 50 and a standard deviation of 10 (higher scores indicate worse functioning) | Posted | Mean | 95% Confidence Interval | T-Score | 12 months |
|
|
|
| Secondary | Child Behavior Checklist | The Child Behavior Checklist (CBCL), is a widely used and validated caregiver-completed survey of behavior competencies that yields standardized, age-adjusted scores on internalizing, externalizing and attentional behavior difficulties81, 82. All scores are T scores with a mean of 50 and standard deviation of 10 (higher scores indicate worse functioning). | Posted | Mean | 95% Confidence Interval | T-Score | 12-Months |
|
|
|
| 66 |
| 86 |
| 1 |
| 86 |
| 66 |
| 86 |
| EG001 | Placebo | Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline). Placebo: One spray per nostril, per day. | 16 | 36 | 0 | 36 | 16 | 36 |
| Upper Respiratory Tract (including cough) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Gastrointestinal Tract | Gastrointestinal disorders | Non-systematic Assessment |
|
| Other Infections | Infections and infestations | Non-systematic Assessment |
|
| Sleep Apnea Exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Other Illness | General disorders | Non-systematic Assessment |
|
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D017670 |
| Sodium Compounds |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Total Behavior Problems |
|
| Attention |
|