Obstructive Sleep ApneaIPAdNCT05949164
The IPAd Study: Exploring the Association Between Insomnia and Positive Airway Pressure Adherence in Children
An observational study of Obstructive Sleep Apnea and Hypoventilation, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Sleep-disordered breathing (SDB) is prevalent in children and adolescents and untreated SDB impacts key indicators of physical and psychosocial health. Positive airway pressure (PAP) therapy is highly effective for the treatment of SDB and is associated with favorable clinical outcomes but is limited by poor… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Obstructive Sleep Apnea, Hypoventilation, Central Sleep Apnea
- What is being tested?
- Insomnia
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 216 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2023to 1 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolescents established on PAP therapy
Participant Inclusion Criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Children aged 4-17 years old
- Prescribed PAP therapy for at least 6 months
Participant Exclusion Criteria
An individual or caregiver who meets one or more of the following criteria will be excluded from participation in this study:
- Limited knowledge and proficiency in English to complete the study as judged by the clinical team.
Trial locations and contacts
1 site in 1 country.
About this study
Sleep-disordered breathing (SDB) is prevalent in children and adolescents and untreated SDB impacts key indicators of physical and psychosocial health. Positive airway pressure (PAP) therapy is highly effective for the treatment of SDB and is associated with favorable clinical outcomes but is limited by poor adherence. Emerging literature in adults suggests that intolerance to PAP therapy may be related to coexisting insomnia. However, the presence of insomnia in children with known SDB as well as its impact on PAP adherence have not been explored. This proposal will explore the association of coexisting insomnia on PAP adherence in children with SDB using a cross-sectional study design. The investigators will assess the association between insomnia and PAP therapy adherence, measured as the mean minutes of nightly PAP usage over 6 months of use on objective downloads.
Read the detailed description
Sleep-disordered breathing (SDB) is prevalent in children and adolescents and untreated SDB impacts key indicators of physical and psychosocial health. Positive airway pressure (PAP) therapy is highly effective for the treatment of SDB and is associated with favorable clinical outcomes but is limited by poor adherence. Emerging literature in adults suggests that intolerance to PAP therapy may be related to coexisting insomnia. This study addresses a critical knowledge gap regarding the association between insomnia and PAP therapy adherence amongst children with SDB. These results will inform future prospective studies on targeted effective interventions to improve PAP adherence in children with SDB.
SDB encompasses a range of breathing disorders during sleep including obstructive sleep apnea (OSA), central sleep apnea (CSA), and hypoventilation. PAP therapy is a common treatment modality for SDB that is often implemented after targeted treatment strategies do not fully cure SDB. PAP therapy, which delivers pressurised air via nasal or oronasal interfaces, effectively distends the upper airway to ameliorate OSA and can assist ventilation with pressure support breaths. PAP is highly efficacious when used on a nightly basis and is typically required for many years into adulthood. The use of PAP has been associated with increased survival and improved health-related quality of life in people with neuromuscular disease. However, SDB remains undertreated or untreated in many children due to poor adherence. A deeper understanding of associations with PAP adherence across the diagnostic spectrum may yield greater benefits for all children on PAP therapy.
Insomnia is highly prevalent in childhood, occurring in up to 37% of children. Insomnia is associated with reduced cognition and academic functioning as well as reduced health-related quality of life, substance use, and increased risk of psychiatric problems. There is emerging evidence that insomnia commonly coexists with OSA in children. A bi-directional causal relationship likely exists whereby OSA is exacerbated by sleep fragmentation, hyper-arousal, and modified sleep architecture associated with insomnia whereas insomnia symptoms are induced by repeated post-obstruction awakenings in OSA. Of importance is that coexisting insomnia and OSA is associated with greater morbidity than either condition alone. To date, there is minimal reported literature on coexisting insomnia with other SDB including CSA and nocturnal hypoventilation. Although similar pathophysiological mechanisms may exist for CSA, there has been little reported in the literature regarding these relationships.
More recently, insomnia has been identified as a risk factor for reduced PAP therapy adherence rates in adult populations due to hypersensitivity to PAP equipment side effects, early discontinuation of therapy, and reduced sleep duration. The impact of insomnia on PAP adherence has never been explored in children. Further, the impact of insomnia on PAP adherence in populations with other SDB diagnoses other than OSA has yet to be explored. Elucidating the impact of coexisting insomnia on PAP adherence may inform future targeted management strategies to improve PAP adherence, such as the addition of cognitive behavioral therapy, and may lead to improved outcomes in children with SDB.
- Being tested
- Insomnia
- Medical subject headings
- Sleep Apnea, Obstructive, Hypoventilation, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsomniaBehavioural
The primary exposure is insomnia
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Children able to answer questionnaires independently | Children who are deemed by a healthcare professional to be able to answer questionnaires independently (group 1) will be asked to complete self-reported questionnaires. Caregivers will also be asked to complete proxy-reported questionnaires. Receives: Behavioral: Insomnia | |
| Group 2: Children unable to answer questionnaires | The caregivers of children who are deemed by a healthcare professional to be unable to answer questionnaires (group 2) will be invited to complete proxy-reported questionnaires only. There are no self-reported questionnaires for this group. Receives: Behavioral: Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAP therapy adherence
PAP therapy adherence measured as the mean minutes of nightly PAP usage over 6 months
Measured: 6 months
Secondary outcomes (40)
PAP therapy adherence
PAP therapy adherence expressed as a percentage of total sleep time
Measured: 6 months
PAP therapy adherence
PAP therapy adherence measured as the mean minutes of nightly PAP usage over 3 months
Measured: 3 months
PAP therapy adherence
PAP therapy adherence expressed as a percentage of total sleep time
Measured: 3 months
PAP therapy adherence
PAP therapy adherence measured as the mean minutes of nightly PAP usage over 2 weeks
Measured: 2 weeks
PAP therapy adherence
PAP therapy adherence expressed as a percentage of total sleep time
Measured: 2 weeks
PAP therapy adherence
PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 4 hours per night for 70% of nights)
Measured: 3 months
PAP therapy adherence
PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 6 hours per night for 70% of nights)
Measured: 3 months
PAP therapy adherence
PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 4 hours per night for 70% of nights)
Measured: 6 months
PAP therapy adherence
PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 6 hours per night for 70% of nights)
Measured: 6 months
Physical Well-being (percentage rank)
The Physical Well-being Scale from the KIDSCREEN-27 questionnaire will be used. The percentage rank range is 0-100, with lower scores indicating lower physical well-being.
Measured: 1 week
Psychological Well-being (percentage rank)
The Psychological Well-being Scale from the KIDSCREEN-27 questionnaire will be used. The percentage rank range is 0-100, with lower scores indicating a "dissatisfaction with life".
Measured: 1 week
Autonomy and Parent Relation (percentage rank)
The Autonomy and Parent Relation Well-being Scale from the KIDSCREEN-27 questionnaire will be used. The percentage rank range is 0-100, with lower scores indicating lower autonomy.
Measured: 1 week
Self-Perception (percentage rank)
The Self-Perception Scale from the KIDSCREEN-27 questionnaire will be used. The percentage rank range is 0-100, with lower scores indicating lower self-perception.
Measured: 1 week
Social Support and Peers (percentage rank)
The Social Support and Peers Scale from the KIDSCREEN-27 questionnaire will be used. The percentage rank range is 0-100, with lower scores indicating lower social support.
Measured: 1 week
Daytime Sleepiness
The Epworth Sleepiness Scale is scored from 0-24, with higher scores indicating greater sleepiness.
Measured: 1 month
Depressive Symptoms (T-score)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v2.0 - Depressive Symptoms Questionnaire generates a T-score. Higher scores indicate increased depressive symptoms (patient-reported questionnaire range 35.2-82.4).
Measured: 7 days
Depressive Symptoms (T-score)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Bank v2.0 - Depressive Symptoms Questionnaire generates a T-score. Higher scores indicate increased depressive symptoms (proxy-reported questionnaire range 36.2-84.7).
Measured: 7 days
Anxiety Symptoms (T-score)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Bank v2.0 - Anxiety Questionnaire generates a T-score. Higher scores indicate increased anxiety symptoms (patient-reported questionnaire range 33.5-83.3).
Measured: 7 days
Anxiety Symptoms (T-score)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Bank v2.0 - Anxiety Questionnaire generates a T-score. Higher scores indicate increased anxiety symptoms (proxy-reported questionnaire range 34.6-86.4).
Measured: 7 days
Chronotype
Measured with the Children's Chronotype Questionnaire. The chronotype categorizations including morningness, eveningness, and neither.
Measured: 4 week
Chronotype
Measured with the Reduced Morningness-Eveningness questionnaire. The chronotype categorizations including morningness, eveningness, and neither.
Measured: 4 week
Chronotype
Measured with the Munich Chronotype Questionnaire for Children and Adolescents. The chronotype categorizations including morningness, eveningness, and neither.
Measured: 4 week
Mid-Sleep Point
Measured with the Munich Chronotype Questionnaire for Children and Adolescents
Measured: 4 week
Mid-Sleep Point
Measured with the Children's Chronotype Questionnaire
Measured: 4 week
Sleep Hygiene (total score)
The Adolescent Sleep Hygiene Scale total score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Measured: 1 month
Sleep Hygiene (Physiological Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Measured: 1 month
Sleep Hygiene (Behavioral Arousal Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Measured: 1 month
Sleep Hygiene (Cognitive/Emotional Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Measured: 1 month
Sleep Hygiene (Sleep Environment Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Measured: 1 month
Sleep Hygiene (Sleep Stability Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Measured: 1 month
Sleep Hygiene (Daytime Sleep Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Measured: 1 month
Sleep Hygiene (Substances Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Measured: 1 month
Sleep Hygiene (Bedtime Routine Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Measured: 1 month
Adherence Barriers to CPAP
The score range for the Adherence Barriers to CPAP Questionnaire is 31-155. Higher scores indicate more barriers.
Measured: 2 weeks
Total Difficulties Score
The Strengths and Difficulties Questionnaire generates a total difficulties score ranging from 0-40, with higher scores indicating greater behavioral difficulty.
Measured: 6 months
Emotional Problems Score
The Strengths and Difficulties Questionnaire generates an emotional problems score ranging from 0-10, with higher scores indicating greater difficulty.
Measured: 6 months
Conduct Problems Score
The Strengths and Difficulties Questionnaire generates a conduct problems score ranging from 0-10, with higher scores indicating greater difficulty.
Measured: 6 months
Hyperactivity Score
The Strengths and Difficulties Questionnaire generates a hyperactivity score ranging from 0-10, with higher scores indicating greater difficulty.
Measured: 6 months
Peer Problems Score
The Strengths and Difficulties Questionnaire generates a peer problems score ranging from 0-10, with higher scores indicating greater difficulty.
Measured: 6 months
Prosocial Score
The Strengths and Difficulties Questionnaire generates a prosocial score ranging from 0-10, with higher scores indicating greater prosocial behavior.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start16 May 2023
- Primary completion1 May 2024
- Study completion1 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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Indra Narang, The Hospital for Sick Children
- Investigators
- Indra Narang, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949164
- Sponsor's protocol ID
- 1000080572
- Acronym
- IPAd
- Status last verified
- May 2025
- First submitted
- 24 Jun 2023
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IPAd Study: Exploring the Association Between Insomnia and Positive Airway Pressure Adherence in Children
- ClinicalTrials.gov ID
- NCT05949164
- Acronym / sponsor ID
- IPAd / 1000080572
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 17 Jul 2023 (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-disordered breathing (SDB) is prevalent in children and adolescents and untreated SDB impacts key indicators of physical and psychosocial health. Positive airway pressure (PAP) therapy is highly effective for the treatment of SDB and is associated with favorable clinical outcomes but is limited by poor adherence. Emerging literature in adults suggests that intolerance to PAP therapy may be related to coexisting insomnia. However, the presence of insomnia in children with known SDB as well as its impact on PAP adherence have not been explored. This proposal will explore the association of coexisting insomnia on PAP adherence in children with SDB using a cross-sectional study design. The investigators will assess the association between insomnia and PAP therapy adherence, measured as the mean minutes of nightly PAP usage over 6 months of use on objective downloads.
Detailed description
Sleep-disordered breathing (SDB) is prevalent in children and adolescents and untreated SDB impacts key indicators of physical and psychosocial health. Positive airway pressure (PAP) therapy is highly effective for the treatment of SDB and is associated with favorable clinical outcomes but is limited by poor adherence. Emerging literature in adults suggests that intolerance to PAP therapy may be related to coexisting insomnia. This study addresses a critical knowledge gap regarding the association between insomnia and PAP therapy adherence amongst children with SDB. These results will inform future prospective studies on targeted effective interventions to improve PAP adherence in children with SDB.
SDB encompasses a range of breathing disorders during sleep including obstructive sleep apnea (OSA), central sleep apnea (CSA), and hypoventilation. PAP therapy is a common treatment modality for SDB that is often implemented after targeted treatment strategies do not fully cure SDB. PAP therapy, which delivers pressurised air via nasal or oronasal interfaces, effectively distends the upper airway to ameliorate OSA and can assist ventilation with pressure support breaths. PAP is highly efficacious when used on a nightly basis and is typically required for many years into adulthood. The use of PAP has been associated with increased survival and improved health-related quality of life in people with neuromuscular disease. However, SDB remains undertreated or untreated in many children due to poor adherence. A deeper understanding of associations with PAP adherence across the diagnostic spectrum may yield greater benefits for all children on PAP therapy.
Insomnia is highly prevalent in childhood, occurring in up to 37% of children. Insomnia is associated with reduced cognition and academic functioning as well as reduced health-related quality of life, substance use, and increased risk of psychiatric problems. There is emerging evidence that insomnia commonly coexists with OSA in children. A bi-directional causal relationship likely exists whereby OSA is exacerbated by sleep fragmentation, hyper-arousal, and modified sleep architecture associated with insomnia whereas insomnia symptoms are induced by repeated post-obstruction awakenings in OSA. Of importance is that coexisting insomnia and OSA is associated with greater morbidity than either condition alone. To date, there is minimal reported literature on coexisting insomnia with other SDB including CSA and nocturnal hypoventilation. Although similar pathophysiological mechanisms may exist for CSA, there has been little reported in the literature regarding these relationships.
More recently, insomnia has been identified as a risk factor for reduced PAP therapy adherence rates in adult populations due to hypersensitivity to PAP equipment side effects, early discontinuation of therapy, and reduced sleep duration. The impact of insomnia on PAP adherence has never been explored in children. Further, the impact of insomnia on PAP adherence in populations with other SDB diagnoses other than OSA has yet to be explored. Elucidating the impact of coexisting insomnia on PAP adherence may inform future targeted management strategies to improve PAP adherence, such as the addition of cognitive behavioral therapy, and may lead to improved outcomes in children with SDB.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Children able to answer questionnaires independently | – | Behavioral: InsomniaChildren who are deemed by a healthcare professional to be able to answer questionnaires independently (group 1) will be asked to complete self-reported questionnaires. Caregivers will also be asked to complete proxy-reported questionnaires. |
| Group 2: Children unable to answer questionnaires | – | Behavioral: InsomniaThe caregivers of children who are deemed by a healthcare professional to be unable to answer questionnaires (group 2) will be invited to complete proxy-reported questionnaires only. There are no self-reported questionnaires for this group. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescents established on PAP therapy
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 |
|---|---|---|
| InsomniaThe primary exposure is insomnia | Behavioural | Group 1: Children able to answer questionnaires independently, Group 2: Children unable to answer questionnaires |
Primary outcome
PAP therapy adherence
Time frame: 6 months
PAP therapy adherence measured as the mean minutes of nightly PAP usage over 6 months
40 secondary outcomes
PAP therapy adherence
Time frame: 6 months
PAP therapy adherence
Time frame: 3 months
PAP therapy adherence
Time frame: 3 months
PAP therapy adherence
Time frame: 2 weeks
PAP therapy adherence
Time frame: 2 weeks
PAP therapy adherence
Time frame: 3 months
PAP therapy adherence
Time frame: 3 months
PAP therapy adherence
Time frame: 6 months
PAP therapy adherence
Time frame: 6 months
Physical Well-being (percentage rank)
Time frame: 1 week
Psychological Well-being (percentage rank)
Time frame: 1 week
Autonomy and Parent Relation (percentage rank)
Time frame: 1 week
Self-Perception (percentage rank)
Time frame: 1 week
Social Support and Peers (percentage rank)
Time frame: 1 week
Daytime Sleepiness
Time frame: 1 month
Depressive Symptoms (T-score)
Time frame: 7 days
Depressive Symptoms (T-score)
Time frame: 7 days
Anxiety Symptoms (T-score)
Time frame: 7 days
Anxiety Symptoms (T-score)
Time frame: 7 days
Chronotype
Time frame: 4 week
Chronotype
Time frame: 4 week
Chronotype
Time frame: 4 week
Mid-Sleep Point
Time frame: 4 week
Mid-Sleep Point
Time frame: 4 week
Sleep Hygiene (total score)
Time frame: 1 month
Sleep Hygiene (Physiological Factor)
Time frame: 1 month
Sleep Hygiene (Behavioral Arousal Factor)
Time frame: 1 month
Sleep Hygiene (Cognitive/Emotional Factor)
Time frame: 1 month
Sleep Hygiene (Sleep Environment Factor)
Time frame: 1 month
Sleep Hygiene (Sleep Stability Factor)
Time frame: 1 month
Sleep Hygiene (Daytime Sleep Factor)
Time frame: 1 month
Sleep Hygiene (Substances Factor)
Time frame: 1 month
Sleep Hygiene (Bedtime Routine Factor)
Time frame: 1 month
Adherence Barriers to CPAP
Time frame: 2 weeks
Total Difficulties Score
Time frame: 6 months
Emotional Problems Score
Time frame: 6 months
Conduct Problems Score
Time frame: 6 months
Hyperactivity Score
Time frame: 6 months
Peer Problems Score
Time frame: 6 months
Prosocial Score
Time frame: 6 months
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 May 2025.
- Individual participant dataSharing planned: No
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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.
Indra Narang, MD principal investigator
The Hospital for Sick Children
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 and Hypoventilation, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 May 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 Canada. 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?
PAP therapy adherence (time frame: 6 months). 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 May 2025.