Sleep Apnea, ObstructiveIPADNCT07176767
The IPAD Cohort Study: Insomnia and Positive Airway Pressure Adherence in Children and Adolescents
An observational study of Sleep Apnea, Obstructive and Insomnia, run by Lena Xiao at 1 site in Canada.
Trial summary
Positive Airway Pressure (PAP) is a treatment used to help people with sleep-disordered breathing, particularly those with obstructive sleep apnea (OSA). The device delivers pressurized air through a mask to keep the airways open during sleep, improving breathing and preventing interruptions in sleep. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Insomnia
- What is being tested?
- Positive airway pressure therapy
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jun 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants will be recruited from two tertiary care academic hospitals, The Hospital for Sick Children (Toronto, Canada) and British Columbia Children's Hospital (BCCH) (Vancouver, Canada).
Who may be able to join
- Children aged 8-18 years old
- Obstructive apnea-hypopnea index ≥ 5/hour on baseline diagnostic polysomnogram (PSG)
- Newly prescribed PAP therapy
Who cannot join
- 1) Developmental disability precluding ability to answer questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3N1
Lena J Xiao, MD MSc, 6048752345 ext. 7606, lena.xiao@cw.bc.ca
Macyn LY Leung, MSc, 6048752345 ext. 7606, macyn.leung@bcchr.ca
About this study
Positive Airway Pressure (PAP) is a treatment used to help people with sleep-disordered breathing, particularly those with obstructive sleep apnea (OSA). The device delivers pressurized air through a mask to keep the airways open during sleep, improving breathing and preventing interruptions in sleep.
Studying how insomnia affects PAP adherence in children can help improve future treatments.
However, no long-term studies have looked at this in children. Based on previous research, the investigators plan to conduct a study across multiple centers focusing on children with OSA starting PAP therapy. The study will explore how insomnia affects PAP adherence and how race and ethnicity play a role.
Read the detailed description
The first line of treatment for obstructive sleep apnea (OSA) is positive airway pressure (PAP) therapy, yet children have a less than 50% adherence rate, leaving many undertreated for this condition. Insomnia has been established as a modifiable risk factor for lowering PAP therapy adherence in adults with comorbid insomnia and sleep apnea (COMISA), and research has shown that treating insomnia with cognitive behavioural therapy for insomnia (CBTi) improved PAP adherence in adults. This is an important step forward for improving COMISA treatment outcomes, but cannot yet be applied to children without researching this relationship in paediatric populations. This study will address this research gap by conducting a thorough, in-depth evaluation of the association between paediatric COMISA and PAP adherence. The investigators aim to find whether a causal relationship exists between insomnia and PAP adherence in children with OSA, which has never been assessed longitudinally in children.
This multicenter study will be conducted at two tertiary care academic hospitals: The Hospital for Sick Children (Toronto, Canada) and British Columbia Children's Hospital (BCCH) (Vancouver, Canada). This study will include 82 participants from a diverse population to assess the association between race and ethnicity with PAP therapy adherence, based on previous research showing that being part of a self-identified minority is associated with lower PAP therapy adherence. Participants and caregivers will be asked to complete questionnaires regarding insomnia, sleep behaviour and quality of life at baseline prior to PAP therapy initiation. Electronic follow up questionnaires will be administered at 1, 2, and 3 months after PAP therapy initiation and PAP download data will be completed remotely. The primary objective of this study is to evaluate the impact of baseline insomnia on PAP therapy adherence at 3 months based on self-identified racial and ethnic minority. The results of this study will provide treatment insight and improvement to children with COMISA being treated with PAP therapy.
- Conditions
- Sleep Apnea, Obstructive, Insomnia
- Being tested
- Positive airway pressure therapy
- Keywords
- Obstructive Sleep Apnea, Insomnia, Pediatric Sleep, Positive Airway Pressure Adherence
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive airway pressure therapyDevice
Also called Continuous positive airway pressure therapy, Bilevel positive airway pressure therapy
Initiation of continuous or bilevel positive airway pressure therapy
| Study group | Role | What they receive |
|---|---|---|
| OSA Children Starting PAP | Children aged 8-18 years old diagnosed with obstructive sleep apnea (OSA) who are to be initiated on Positive Airway Pressure (PAP) therapy. Children and their caregivers must be willing and able to complete questionnaires about sleep as well as physical and mental health. Receives: Device: Positive airway pressure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean minutes of nightly PAP usage
Adherence will be determined objectively using ventilator download data (days 60-90 after PAP initiation)
Measured: 90 days
Secondary outcomes (28)
Mean minutes of nightly PAP usage
Adherence will be determined objectively using ventilator download data (days 0-30 and 30-60 after PAP initiation)
Measured: 30, 60 days
Self-Reported Sense of Mastery (Caregiver)
The self-reported Pearlin Mastery Scale will be used to measure the caregiver's mastery. Scores range from 7 to 28, with higher scores indicating greater levels of mastery.
Measured: 0, 90 days
Self-Reported Sense of Mastery (Participant)
The self-reported Pearlin Mastery Scale will be used to measure the participant's individual mastery. Scores range from 7 to 28, with higher scores indicating greater levels of mastery.
Measured: 0, 90 days
Self-Reported Psychological Scale (Percentage Rank)
The self-reported Psychological Scale from the KIDSCREEN-10 questionnaire will be used to measure health-related quality of life. The score ranges from 10-50, with lower scores indicating a "dissatisfaction with life".
Measured: 0, 90 days
Self-Reported Psychological Scale
The self-reported Psychological Scale from the Strengths and Difficulties questionnaire will be used. Scores range from 0-50 with higher scores indicating more difficulties and lower scores indicating more strengths.
Measured: 0, 90 days
Self-Reported Sleep Diary
The self-reported National Institutes of Health (NIH) 1-week Sleep Diary will be used to record the quality and quantity of sleep.
Measured: 0, 90 days
Caregiver-Reported Insomnia Questionnaire
The caregiver-reported Pediatric Insomnia Severity Index will be used to measure the severity of pediatric insomnia symptoms. Scores range from 0 to 30, with higher scores indicating greater insomnia severity.
Measured: 0, 90 days
Self-Reported Insomnia Questionnaire (Participant)
The self-reported Insomnia Severity Index will be used to measure the nature, severity and impact of the participant's insomnia. Scores range from 0 to 28, with higher scores indicating greater insomnia severity.
Measured: 0, 30, 60, 90 days
Self-Reported Insomnia Questionnaire (Participant)
The self-reported Insomnia Severity Index will be used to diagnose insomnia in the participant. Children will be classified as having insomnia using a cut-off of ≥ 9 points, based on the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition.
Measured: 0, 30, 60, 90 days
Self-Reported Insomnia Questionnaire (Caregiver)
The self-reported Insomnia Severity Index will be used to measure the nature, severity and impact of the caregiver's insomnia. Scores range from 0 to 28, with higher scores indicating greater insomnia severity.
Measured: 0, 90 days
Self-Reported Insomnia Questionnaire (Caregiver)
The self-reported Insomnia Severity Index will be used to diagnose insomnia in the caregiver. Caregiver's will be classified as having insomnia using a cut-off of ≥ 9 points, based on the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition.
Measured: 0, 90 days
Self-Reported Chronotype Questionnaire
The self-reported Munich Chronotype Questionnaire will be used to measure participant chronotype. Scores range from 16 to 86 with scores below 42 indicating "evening types", scores between 42-58 indicating "intermediate types" and scores above 58 indicating "morning types".
Measured: 0, 90 days
Self-Reported Chronotype Questionnaire
The self-reported Morningness/Eveningness Questionnaire will be used to measure differences in activeness and alertness in the mornings and evenings. Scores range from 16 to 86, with lower scores representing evening preference and higher scores representing morning preference.
Measured: 0, 90 days
Caregiver's Self-Reported Chronotype Questionnaire
The self-reported Morningness/Eveningness Questionnaire will be used to measure the caregiver's differences in activeness and alertness in the mornings and evenings. Scores range from 16 to 86, with lower scores representing evening preference and higher scores representing morning preference.
Measured: 0, 90 days
Self-Reported Daytime Sleepiness Questionnaire
The self-reported Epworth Sleepiness Scale will be used to measure daytime sleepiness. Scores range from 0-24 with lower score indicating less daytime sleepiness.
Measured: 0, 90 days
Self-Reported Caffeine Intake Questionnaire
The self-reported Caffeine Consumption Questionnaire-Revised will be used to measure weekly caffeine intake. The quantity and frequency of caffeinated products reported is used to estimate the average daily caffeine consumption in mg.
Measured: 0, 90 days
Self-Reported Sleep Hygiene Questionnaire
The self-reported Adolescent Sleep Hygiene Scale (ASHS) will be used to assess sleep habits and hygiene practices. The 33-item scale contains 28 quantitative items, which are scored as the following: never (0%) = 1; once in a while (20%) = 2; sometimes (40%) = 3; quite often (60%) = 4; frequently, if not always (80%) = 5; always (100%) = 6. Total scores range from 28-168, with higher scores indicating greater sleep hygiene.
Measured: 0, 90 days
Caregiver-Reported Global Rating Scale of Change
The caregiver-reported Global Rating Scale of Change will be used to measure the caregiver's perceived improvement or deterioration of the child's quality of life over time. The scale ranges from -7 to +7, with greater scores indicating improvements in quality of life.
Measured: 90 days
Self-Reported Global Rating Scale of Change
The self-reported Global Rating Scale of Change will be used to measure the participant's perceived improvement or deterioration of their quality of life over time. The scale ranges from -7 to +7, with greater scores indicating improvements in quality of life.
Measured: 90 days
Self-Reported PAP Adherence Questionnaire
The self-reported Adherence Barriers to CPAP Questionnaire will be used to estimate the participant's success or failure to use their PAP. The score ranges from 31 to 155, with greater scores indicating a higher number and severity of CPAP barriers.
Measured: 90 days
Self-Reported Psychological (Total Anxiety) Subscale
The self-reported Total Anxiety Subscale (major outcome) from the Revised Child Anxiety and Depression Scale will be used. The raw score from the subscale, which ranges from 0-45, will be used to calculate the T score by taking into consideration development level and gender. A T score of 65 or higher indicates a score borderline the clinical threshold and a T score of 70 or higher indicates a score above the clinical threshold.
Measured: 0, 90 days
Self-Reported Psychological (Total Depression) Scale
The self-reported Total Depression (major outcome) from the Revised Child Anxiety and Depression Scale will be used. The raw score from the subscale, which ranges from 0-30, will be used to calculate the T score by taking into consideration development level and gender. A T score of 65 or higher indicates a score borderline the clinical threshold and a T score of 70 or higher indicates a score above the clinical threshold.
Measured: 0, 90 days
Self-Reported Psychological (Social Phobia) Scale
The self-reported Social Phobia Subscale (major outcome) from the Revised Child Anxiety and Depression Scale will be used. The raw score from the subscale, which ranges from 0-27, will be used to calculate the T score by taking into consideration development level and gender. A T score of 65 or higher indicates a score borderline the clinical threshold and a T score of 70 or higher indicates a score above the clinical threshold.
Measured: 0, 90 days
Self-Reported Psychological (Panic Disorder) Scale
The self-reported Panic Disorder Subscale (major outcome) from the Revised Child Anxiety and Depression Scale will be used. The raw score from the subscale, which ranges from 0-27, will be used to calculate the T score by taking into consideration development level and gender. A T score of 65 or higher indicates a score borderline the clinical threshold and a T score of 70 or higher indicates a score above the clinical threshold.
Measured: 0, 90 days
Self-Reported Psychological (Major Depression) Scale
The self-reported Major Depression Subscale (major outcome) from the Revised Child Anxiety and Depression Scale will be used. The raw score from the subscale, which ranges from 0-30, will be used to calculate the T score by taking into consideration development level and gender. A T score of 65 or higher indicates a score borderline the clinical threshold and a T score of 70 or higher indicates a score above the clinical threshold.
Measured: 0, 90 days
Self-Reported Psychological (Separation Anxiety) Scale
The self-reported Separation Anxiety Subscale (major outcome) from the Revised Child Anxiety and Depression Scale will be used. The raw score from the subscale, which ranges from 0-21, will be used to calculate the T score by taking into consideration development level and gender. A T score of 65 or higher indicates a score borderline the clinical threshold and a T score of 70 or higher indicates a score above the clinical threshold.
Measured: 0, 90 days
Self-Reported Psychological (Generalized Anxiety) Scale
The self-reported Generalized Anxiety Subscale (major outcome) from the Revised Child Anxiety and Depression Scale will be used. The raw score from the subscale, which ranges from 0-18, will be used to calculate the T score by taking into consideration development level and gender. A T score of 65 or higher indicates a score borderline the clinical threshold and a T score of 70 or higher indicates a score above the clinical threshold.
Measured: 0, 90 days
Self-Reported Psychological (Obsessive-Compulsive) Scale
The self-reported Obsessive-Compulsive Subscale (major outcome) from the Revised Child Anxiety and Depression Scale will be used. The raw score from the subscale, which ranges from 0-18, will be used to calculate the T score by taking into consideration development level and gender. A T score of 65 or higher indicates a score borderline the clinical threshold and a T score of 70 or higher indicates a score above the clinical threshold.
Measured: 0, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start12 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lena Xiao
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine, The Hospital for Sick Children
- Responsible party
- Sponsor-investigator, Lena Xiao, University of British Columbia
- Investigators
- Lena J Xiao, MD, MSc, Principal investigator, Provincial Health Services Authority British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176767
- Sponsor's protocol ID
- H25-00289
- Other IDs
- 354-FP-24
- Acronym
- IPAD
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 23 Sep 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IPAD Cohort Study: Insomnia and Positive Airway Pressure Adherence in Children and Adolescents
- ClinicalTrials.gov ID
- NCT07176767
- Acronym / sponsor ID
- IPAD / H25-00289
- Conditions
- Sleep Apnea, Obstructive, Insomnia
- Keywords
- Obstructive Sleep Apnea, Insomnia, Pediatric Sleep, Positive Airway Pressure Adherence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Lena XiaoUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine, The Hospital for Sick Children
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Sep 2025 (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.
Positive Airway Pressure (PAP) is a treatment used to help people with sleep-disordered breathing, particularly those with obstructive sleep apnea (OSA). The device delivers pressurized air through a mask to keep the airways open during sleep, improving breathing and preventing interruptions in sleep.
Studying how insomnia affects PAP adherence in children can help improve future treatments.
However, no long-term studies have looked at this in children. Based on previous research, the investigators plan to conduct a study across multiple centers focusing on children with OSA starting PAP therapy. The study will explore how insomnia affects PAP adherence and how race and ethnicity play a role.
Detailed description
The first line of treatment for obstructive sleep apnea (OSA) is positive airway pressure (PAP) therapy, yet children have a less than 50% adherence rate, leaving many undertreated for this condition. Insomnia has been established as a modifiable risk factor for lowering PAP therapy adherence in adults with comorbid insomnia and sleep apnea (COMISA), and research has shown that treating insomnia with cognitive behavioural therapy for insomnia (CBTi) improved PAP adherence in adults. This is an important step forward for improving COMISA treatment outcomes, but cannot yet be applied to children without researching this relationship in paediatric populations. This study will address this research gap by conducting a thorough, in-depth evaluation of the association between paediatric COMISA and PAP adherence. The investigators aim to find whether a causal relationship exists between insomnia and PAP adherence in children with OSA, which has never been assessed longitudinally in children.
This multicenter study will be conducted at two tertiary care academic hospitals: The Hospital for Sick Children (Toronto, Canada) and British Columbia Children's Hospital (BCCH) (Vancouver, Canada). This study will include 82 participants from a diverse population to assess the association between race and ethnicity with PAP therapy adherence, based on previous research showing that being part of a self-identified minority is associated with lower PAP therapy adherence. Participants and caregivers will be asked to complete questionnaires regarding insomnia, sleep behaviour and quality of life at baseline prior to PAP therapy initiation. Electronic follow up questionnaires will be administered at 1, 2, and 3 months after PAP therapy initiation and PAP download data will be completed remotely. The primary objective of this study is to evaluate the impact of baseline insomnia on PAP therapy adherence at 3 months based on self-identified racial and ethnic minority. The results of this study will provide treatment insight and improvement to children with COMISA being treated with PAP therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSA Children Starting PAP | – | Device: Positive airway pressure therapyChildren aged 8-18 years old diagnosed with obstructive sleep apnea (OSA) who are to be initiated on Positive Airway Pressure (PAP) therapy. Children and their caregivers must be willing and able to complete questionnaires about sleep as well as physical and mental health. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants will be recruited from two tertiary care academic hospitals, The Hospital for Sick Children (Toronto, Canada) and British Columbia Children's Hospital (BCCH) (Vancouver, Canada).
Key inclusion criteria (3 listed)
- Children aged 8-18 years old
- Obstructive apnea-hypopnea index ≥ 5/hour on baseline diagnostic polysomnogram (PSG)
- Newly prescribed PAP therapy
Key exclusion criteria (1 listed)
- 1) Developmental disability precluding ability to answer questionnaires
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 |
|---|---|---|
| Positive airway pressure therapyAlso: Continuous positive airway pressure therapy, Bilevel positive airway pressure therapyInitiation of continuous or bilevel positive airway pressure therapy | Device | OSA Children Starting PAP |
Primary outcome
Mean minutes of nightly PAP usage
Time frame: 90 days
Adherence will be determined objectively using ventilator download data (days 60-90 after PAP initiation)
28 secondary outcomes
Mean minutes of nightly PAP usage
Time frame: 30, 60 days
Self-Reported Sense of Mastery (Caregiver)
Time frame: 0, 90 days
Self-Reported Sense of Mastery (Participant)
Time frame: 0, 90 days
Self-Reported Psychological Scale (Percentage Rank)
Time frame: 0, 90 days
Self-Reported Psychological Scale
Time frame: 0, 90 days
Self-Reported Sleep Diary
Time frame: 0, 90 days
Caregiver-Reported Insomnia Questionnaire
Time frame: 0, 90 days
Self-Reported Insomnia Questionnaire (Participant)
Time frame: 0, 30, 60, 90 days
Self-Reported Insomnia Questionnaire (Participant)
Time frame: 0, 30, 60, 90 days
Self-Reported Insomnia Questionnaire (Caregiver)
Time frame: 0, 90 days
Self-Reported Insomnia Questionnaire (Caregiver)
Time frame: 0, 90 days
Self-Reported Chronotype Questionnaire
Time frame: 0, 90 days
Self-Reported Chronotype Questionnaire
Time frame: 0, 90 days
Caregiver's Self-Reported Chronotype Questionnaire
Time frame: 0, 90 days
Self-Reported Daytime Sleepiness Questionnaire
Time frame: 0, 90 days
Self-Reported Caffeine Intake Questionnaire
Time frame: 0, 90 days
Self-Reported Sleep Hygiene Questionnaire
Time frame: 0, 90 days
Caregiver-Reported Global Rating Scale of Change
Time frame: 90 days
Self-Reported Global Rating Scale of Change
Time frame: 90 days
Self-Reported PAP Adherence Questionnaire
Time frame: 90 days
Self-Reported Psychological (Total Anxiety) Subscale
Time frame: 0, 90 days
Self-Reported Psychological (Total Depression) Scale
Time frame: 0, 90 days
Self-Reported Psychological (Social Phobia) Scale
Time frame: 0, 90 days
Self-Reported Psychological (Panic Disorder) Scale
Time frame: 0, 90 days
Self-Reported Psychological (Major Depression) Scale
Time frame: 0, 90 days
Self-Reported Psychological (Separation Anxiety) Scale
Time frame: 0, 90 days
Self-Reported Psychological (Generalized Anxiety) Scale
Time frame: 0, 90 days
Self-Reported Psychological (Obsessive-Compulsive) Scale
Time frame: 0, 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 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.
Lena J Xiao, MD, MSc principal investigator
Provincial Health Services Authority British Columbia
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 Sleep Apnea, Obstructive and Insomnia, run by Lena Xiao 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?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 23 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lena J Xiao, MD MSc (6048752345 ext. 7606, lena.xiao@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean minutes of nightly PAP usage (time frame: 90 days). 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 23 Sep 2025.