Obstructive Sleep ApneaDINISASNCT03449550

Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)

A study testing Home Respiratory Polygraphy (HRP) and Standard Polysomnography (PSG) in people with Obstructive Sleep Apnea, run by Hospital Universitario Araba at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To assess the diagnostic validity and cost-effectiveness of a home respiratory polygraphy (HRP) performed at home compared with the standard polysomnography (PSG) in children with clinically suspected Obstructive Sleep Apnea (OSA). Read more about this study

Who is it for?: Ages 2 to 14 years
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: Home Respiratory Polygraphy (HRP) and Standard Polysomnography (PSG)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 320 participants
Where: 1 siteSpain
Study dates: 7 May 2015to 30 Mar 2020
Phase: Interventional
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 2 to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children between 2 and 14 years of age of both sexes consecutively assessed for clinical suspicion of OSA, defined as: snoring children with observed respiratory and / or apnea pauses and / or ventilatory effort during observed sleep, and who were asked for a sleep test
Written informed consent signed.

Who cannot join

Place of residence more than 100 km from the hospital
Psychophysical incapacity to perform the study at home
Severe, unstable or exacerbated cardio-vascular, cerebro-vascular or respiratory disease, that makes it impossible to carry out adequate studies
Children with chronic insomnia and / or depressive syndrome
Children with malformative syndromes, Down Syndrome and neuromuscular diseases
Complete or near complete nasal obstruction that prevents obtaining a quality signal with the HRP
History of surgery and / or previous Positive continuous pressure (CPAP) for OSA

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitario Alava
Vitoria-Gasteiz, Alava, 01009

Other trials in Spain

About this study

Official title: Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)

Read the detailed description

AIMS: To assess the diagnostic validity and cost-effectiveness of a home respiratory polygraphy (HRP) performed at home compared with the standard polysomnography (PSG) in children with clinically suspected Obstructive Sleep Apnea (OSA).

METHODOLOGY: DESIGN: Randomized, prospective, multicenter, double blind and crossover trial. The study will include 320 children, both sexes, with clinical suspicion of obstructive sleep apnea (OSA). MEASUREMENTS: To all patients with clinical suspected OSA and referred to the sleep units, the following questionnaires and measurements will be performed: a) clinic history; b) Anthropometric variables: weight, height, body mass index, neck circumference and percentile; c) Chervin questionnaire, quality of life and clinical questionnaires and comorbidity; d) PSG in the sleep laboratory; e) HRP at home; f) Quantitative unbiased proteinic urine analysis and g) Cost-effectiveness variables.

ANALYSIS: Data from HRP and from full PSG will be compared as follows: 1) Agreement of results according to the different apnea-hypopnea index by using the ROC curves; 2) The concordance of the diagnosis and treatment decisions when using clinical findings and data from PSG or HRP at home, 3) All data will be analyzed independently by participating hospitals according the Cohen Kappa method, 4) A diagnosis paradigm based on proteinic defined variables and 5) A cost-effectiveness analysis of the different diagnostic and therapeutic procedures will be performed.

Conditions: Obstructive Sleep Apnea
Being tested: Home Respiratory Polygraphy (HRP), Standard Polysomnography (PSG)
Keywords: Child obstructive sleep apnea, Home Respiratory Polygraphy, Diagnosis, Validity, Polysomnography
Medical subject headings: Sleep Apnea, Obstructive, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Home Respiratory Polygraphy (HRP)Other
Also called Validity
Randomizing to start with home respiratory polygraphy
Standard Polysomnography (PSG)Other
Also called Validity
Randomizing to start with Standard Polysomnography (PSG)
Home Respiratory Polygraphy (HRP)Other
Also called Effectiveness
Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP)
Standard Polysomnography (PSG)Other
Also called Effectiveness
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)

Study groups in NCT03449550
Study group	Role	What they receive
Diagnostic Randomizing	Active comparator	Randomizing to start with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG) Receives: Other: Home Respiratory Polygraphy (HRP); Other: Standard Polysomnography (PSG)
Therapeutic Randomizing	Active comparator	Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG) Receives: Other: Home Respiratory Polygraphy (HRP); Other: Standard Polysomnography (PSG)

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnostic validity of a Home Respiratory Polygraphy (HRP)
To establish the diagnostic validity of home respiratory polygraphy (HRP) compared with the findings obtained with polysomnography (PSG) in the sleep laboratory in children with suspected Obstructive Sleep Apnea (OSA), based on the results of Apnea-hypopnea Index (AHI)
Measured: baseline

Secondary outcomes (9)

Cost effectiveness analysis
Cost-efficacy evaluation: the analysis will be made in both arms based on intention to treat. Only direct costs will be analyzed: the cost of the use of polysomnography and home respiratory polygraphy (Staff and consumable material).
Measured: baseline
Validation of the therapeutic decision
Analyze the concordance in the therapeutic decision using clinical findings and the results of Apnea-Hypopnea Index (AHI) from standard polysomnography (PSG) compared with data from home respiratory polygraphy (HRP)
Measured: 6 month
Validity of the determination of a protein sequence in urine in OSA
To analyze the validity of the determination of a protein sequence in urine, alone or in combination, to establish the diagnosis of OSA and to evaluate its modification over time after the treatment of OSA
Measured: baseline
Pediatric Sleep Questionnaire.
Pediatric Sleep Questionnaire designed to screen for sleep problems in children.The scale consists of 22 parent-reported items examining snoring and breathing problems, daytime sleepiness, inattention, hyperactivity, and other signs and symptoms of apnea including obesity and nocturnal enuresis.
The result is a number, a proportion that ranges from 0.0 to 1.0. Scores >0.33 are considered positive and suggestive of high risk for a pediatric sleep-related breathing disorder
Measured: baseline and at six month
BEARS Sleep screening
BEARS Sleep screening is divided into five major sleep domains (B=Bedtime Issues, E=Excessive Daytime Sleepiness, A=Night Awakenings, R=Regularity and Duration of Sleep, S=Snoring), providing a comprehensive screen for the major sleep disorders affecting children in the 2- to 18-year old range
Measured: baseline and at six month
Quality of life (KINDLR)
The KINDLR is a generic instrument for assessing Health-Related Quality of Life in children and adolescents aged 3 years and older. Consists of 24 Likert-scaled items associated with six dimensions: physical well-being, emotional well-being, self-esteem, family, friends and everyday functioning (school). The response categories cover 3 levels (1=never, 2=sometimes, 3=very often)
Measured: baseline and at six month
Children's sleep habits questionnaire (CSHQ)
Parent-report sleep screening instrument designed for school-aged children.The instrument evaluates the child's sleep based on behavior within eight different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep-disordered breathing, and daytime sleepiness.
Measured: baseline and at six month
Anthropometric variables
Body mass index
Measured: baseline and at six month
Blood pressure
Blood pressure measurements: systolic blood pressure and diastolic blood pressure
Measured: baseline and at six month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 May 201530 Mar 2020

First posted28 Feb 2018
Study start7 May 2015
Primary completion30 Apr 2019
Study completion30 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 320 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03449550
Sponsor's protocol ID: PI14/01187
Acronym: DINISAS
Status last verified: Sep 2021
First submitted: 6 Oct 2017
Last updated: 9 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Luz Alonso-Alvarez M, Canet T, Cubell-Alarco M, Estivill E, Fernandez-Julian E, Gozal D, Jurado-Luque MJ, Lluch-Rosello MA, Martinez-Perez F, Merino-Andreu M, Pin-Arboledas G, Roure N, Sanmarti FX, Sans-Capdevila O, Segarra-Isern F, Tomas-Vila M, Teran-Santos J; Sociedad Espanola de Sueno; Area de Sueno de la Sociedad Espanola de Neumologia y Cirugia Toracica(SEPAR)]. [Consensus document on sleep apnea-hypopnea syndrome in children (full version). Sociedad Espanola de Sueno. El Area de Sueno de la Sociedad Espanola de Neumologia y Cirugia Toracica(SEPAR)]. Arch Bronconeumol. 2011 May;47 Suppl 5:0, 2-18. doi: 10.1016/S0300-2896(11)70026-6. Epub 2011 Jun 22. No abstract available. Spanish.
PubMed 22682520
Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J et al. American Academy of Pediatrics Statement. Clinical practice guideline: diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics109:704-23, 2002.
Alonso-Alvarez ML, Cordero-Guevara JA, Teran-Santos J, Gonzalez-Martinez M, Jurado-Luque MJ, Corral-Penafiel J, Duran-Cantolla J, Kheirandish-Gozal L, Gozal D. Obstructive sleep apnea in obese community-dwelling children: the NANOS study. Sleep. 2014 May 1;37(5):943-9. doi: 10.5665/sleep.3666.
PubMed 24790273
Gileles-Hillel A, Alonso-Alvarez ML, Kheirandish-Gozal L, Peris E, Cordero-Guevara JA, Teran-Santos J, Martinez MG, Jurado-Luque MJ, Corral-Penafiel J, Duran-Cantolla J, Gozal D. Inflammatory markers and obstructive sleep apnea in obese children: the NANOS study. Mediators Inflamm. 2014;2014:605280. doi: 10.1155/2014/605280. Epub 2014 Jun 1.
PubMed 24991089
Reuveni H, Simon T, Tal A, Elhayany A, Tarasiuk A. Health care services utilization in children with obstructive sleep apnea syndrome. Pediatrics. 2002 Jul;110(1 Pt 1):68-72. doi: 10.1542/peds.110.1.68.
PubMed 12093948
Chervin RD, Hedger K, Dillon JE, Pituch KJ. Pediatric sleep questionnaire (PSQ): validity and reliability of scales for sleep-disordered breathing, snoring, sleepiness, and behavioral problems. Sleep Med. 2000 Feb 1;1(1):21-32. doi: 10.1016/s1389-9457(99)00009-x.
PubMed 10733617
Spruyt K, Gozal D. Screening of pediatric sleep-disordered breathing: a proposed unbiased discriminative set of questions using clinical severity scales. Chest. 2012 Dec;142(6):1508-1515. doi: 10.1378/chest.11-3164.
PubMed 22677350
Nixon GM, Kermack AS, Davis GM, Manoukian JJ, Brown KA, Brouillette RT. Planning adenotonsillectomy in children with obstructive sleep apnea: the role of overnight oximetry. Pediatrics. 2004 Jan;113(1 Pt 1):e19-25. doi: 10.1542/peds.113.1.e19.
PubMed 14702490
Marcus CL, Keens TG, Ward SL. Comparison of nap and overnight polysomnography in children. Pediatr Pulmonol. 1992 May;13(1):16-21. doi: 10.1002/ppul.1950130106.
PubMed 1589307
Goodwin JL, Enright PL, Kaemingk KL, Rosen GM, Morgan WJ, Fregosi RF, Quan SF. Feasibility of using unattended polysomnography in children for research--report of the Tucson Children's Assessment of Sleep Apnea study (TuCASA). Sleep. 2001 Dec 15;24(8):937-44. doi: 10.1093/sleep/24.8.937.
PubMed 11766164
Jacob SV, Morielli A, Mograss MA, Ducharme FM, Schloss MD, Brouillette RT. Home testing for pediatric obstructive sleep apnea syndrome secondary to adenotonsillar hypertrophy. Pediatr Pulmonol. 1995 Oct;20(4):241-52. doi: 10.1002/ppul.1950200407.
PubMed 8606854
Moss D, Urschitz MS, von Bodman A, Eitner S, Noehren A, Urschitz-Duprat PM, Schlaud M, Poets CF. Reference values for nocturnal home polysomnography in primary schoolchildren. Pediatr Res. 2005 Nov;58(5):958-65. doi: 10.1203/01.PDR.0000181372.34213.13. Epub 2005 Sep 23.
PubMed 16183829
Alonso Alvarez ML, Teran Santos J, Cordero Guevara JA, Navazo Eguia AI, Ordax Carbajo E, Masa Jimenez JF, Pelayo R. [Reliability of respiratory polygraphy for the diagnosis of sleep apnea-hypopnea syndrome in children]. Arch Bronconeumol. 2008 Jun;44(6):318-23. Spanish.
PubMed 18559221
Brockmann PE, Schaefer C, Poets A, Poets CF, Urschitz MS. Diagnosis of obstructive sleep apnea in children: a systematic review. Sleep Med Rev. 2013 Oct;17(5):331-40. doi: 10.1016/j.smrv.2012.08.004. Epub 2013 Jan 30.
PubMed 23375659
Marcus CL, Moore RH, Rosen CL, Giordani B, Garetz SL, Taylor HG, Mitchell RB, Amin R, Katz ES, Arens R, Paruthi S, Muzumdar H, Gozal D, Thomas NH, Ware J, Beebe D, Snyder K, Elden L, Sprecher RC, Willging P, Jones D, Bent JP, Hoban T, Chervin RD, Ellenberg SS, Redline S; Childhood Adenotonsillectomy Trial (CHAT). A randomized trial of adenotonsillectomy for childhood sleep apnea. N Engl J Med. 2013 Jun 20;368(25):2366-76. doi: 10.1056/NEJMoa1215881. Epub 2013 May 21.
PubMed 23692173

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)
ClinicalTrials.gov ID: NCT03449550
Acronym / sponsor ID: DINISAS / PI14/01187
Conditions: Obstructive Sleep Apnea
Keywords: Child obstructive sleep apnea, Home Respiratory Polygraphy, Diagnosis, Validity, Polysomnography
Study type: Interventional
Recruitment status: Completed
Enrolment: 320 participants (actual)
Lead sponsor: Hospital Universitario ArabaUniversity, hospital or other
Collaborators: Instituto de Salud Carlos III, ResMed, Complejo Hospitalario de Caceres, Hospital Universitario de Burgos, Hospital Universitario Marqués de Valdecilla, Hospital de Basurto, Hospital Vall d'Hebron, Fundación Jimenez Diaz de Madrid, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre, Hospital Clínico Universitario de Valladolid, University of Guadalajara, University of Chicago
Study start: 7 May 2015 (actual)
Primary completion: 30 Apr 2019 (actual)
Study completion: 30 Mar 2020 (actual)
First posted: 28 Feb 2018 (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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Diagnostic Randomizing	Active comparator	Other: Home Respiratory Polygraphy (HRP), Other: Standard Polysomnography (PSG)Randomizing to start with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)
Therapeutic Randomizing	Active comparator	Other: Home Respiratory Polygraphy (HRP), Other: Standard Polysomnography (PSG)Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)

Who may qualify

Ages: 2 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Children between 2 and 14 years of age of both sexes consecutively assessed for clinical suspicion of OSA, defined as: snoring children with observed respiratory and / or apnea pauses and / or ventilatory effort during observed sleep, and who were asked for a sleep test
Written informed consent signed.

Key exclusion criteria (7 listed)

Place of residence more than 100 km from the hospital
Psychophysical incapacity to perform the study at home
Severe, unstable or exacerbated cardio-vascular, cerebro-vascular or respiratory disease, that makes it impossible to carry out adequate studies
Children with chronic insomnia and / or depressive syndrome
Children with malformative syndromes, Down Syndrome and neuromuscular diseases

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
Home Respiratory Polygraphy (HRP)Also: ValidityRandomizing to start with home respiratory polygraphy	Other	Diagnostic Randomizing
Standard Polysomnography (PSG)Also: ValidityRandomizing to start with Standard Polysomnography (PSG)	Other	Diagnostic Randomizing
Home Respiratory Polygraphy (HRP)Also: EffectivenessRandomizing for therapeutic decision taken with home respiratory polygraphy (HRP)	Other	Therapeutic Randomizing
Standard Polysomnography (PSG)Also: EffectivenessRandomizing for therapeutic decision taken with Standard Polysomnography (PSG)	Other	Therapeutic Randomizing

Primary outcome

Diagnostic validity of a Home Respiratory Polygraphy (HRP)
Time frame: baseline
To establish the diagnostic validity of home respiratory polygraphy (HRP) compared with the findings obtained with polysomnography (PSG) in the sleep laboratory in children with suspected Obstructive Sleep Apnea (OSA), based on the results of Apnea-hypopnea Index (AHI)

9 secondary outcomes

Cost effectiveness analysis
Time frame: baseline
Validation of the therapeutic decision
Time frame: 6 month
Validity of the determination of a protein sequence in urine in OSA
Time frame: baseline
Pediatric Sleep Questionnaire.
Time frame: baseline and at six month
BEARS Sleep screening
Time frame: baseline and at six month
Quality of life (KINDLR)
Time frame: baseline and at six month
Children's sleep habits questionnaire (CSHQ)
Time frame: baseline and at six month
Anthropometric variables
Time frame: baseline and at six month
Blood pressure
Time frame: baseline and at six month

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 9 Sep 2021.
Background: PubMed 22682520Luz Alonso-Alvarez M, Canet T, Cubell-Alarco M, Estivill E, Fernandez-Julian E, Gozal D, Jurado-Luque MJ, Lluch-Rosello MA, Martinez-Perez F, Merino-Andreu M, Pin-Arboledas G, Roure N, Sanmarti FX, Sans-Capdevila O, Segarra-Isern F, Tomas-Vila M, Teran-Santos J; Sociedad Espanola de Sueno; Area de Sueno de la Sociedad Espanola de Neumologia y Cirugia Toracica(SEPAR)]. [Consensus document on sleep apnea-hypopnea syndrome in children (full version). Sociedad Espanola de Sueno. El Area de Sueno de la Sociedad Espanola de Neumologia y Cirugia Toracica(SEPAR)]. Arch Bronconeumol. 2011 May;47 Suppl 5:0, 2-18. doi: 10.1016/S0300-2896(11)70026-6. Epub 2011 Jun 22. No abstract available. Spanish.
BackgroundMarcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J et al. American Academy of Pediatrics Statement. Clinical practice guideline: diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics109:704-23, 2002.
Background: PubMed 24790273Alonso-Alvarez ML, Cordero-Guevara JA, Teran-Santos J, Gonzalez-Martinez M, Jurado-Luque MJ, Corral-Penafiel J, Duran-Cantolla J, Kheirandish-Gozal L, Gozal D. Obstructive sleep apnea in obese community-dwelling children: the NANOS study. Sleep. 2014 May 1;37(5):943-9. doi: 10.5665/sleep.3666.
Background: PubMed 24991089Gileles-Hillel A, Alonso-Alvarez ML, Kheirandish-Gozal L, Peris E, Cordero-Guevara JA, Teran-Santos J, Martinez MG, Jurado-Luque MJ, Corral-Penafiel J, Duran-Cantolla J, Gozal D. Inflammatory markers and obstructive sleep apnea in obese children: the NANOS study. Mediators Inflamm. 2014;2014:605280. doi: 10.1155/2014/605280. Epub 2014 Jun 1.
Background: PubMed 12093948Reuveni H, Simon T, Tal A, Elhayany A, Tarasiuk A. Health care services utilization in children with obstructive sleep apnea syndrome. Pediatrics. 2002 Jul;110(1 Pt 1):68-72. doi: 10.1542/peds.110.1.68.
Background: PubMed 10733617Chervin RD, Hedger K, Dillon JE, Pituch KJ. Pediatric sleep questionnaire (PSQ): validity and reliability of scales for sleep-disordered breathing, snoring, sleepiness, and behavioral problems. Sleep Med. 2000 Feb 1;1(1):21-32. doi: 10.1016/s1389-9457(99)00009-x.
Background: PubMed 22677350Spruyt K, Gozal D. Screening of pediatric sleep-disordered breathing: a proposed unbiased discriminative set of questions using clinical severity scales. Chest. 2012 Dec;142(6):1508-1515. doi: 10.1378/chest.11-3164.
Background: PubMed 14702490Nixon GM, Kermack AS, Davis GM, Manoukian JJ, Brown KA, Brouillette RT. Planning adenotonsillectomy in children with obstructive sleep apnea: the role of overnight oximetry. Pediatrics. 2004 Jan;113(1 Pt 1):e19-25. doi: 10.1542/peds.113.1.e19.
Background: PubMed 1589307Marcus CL, Keens TG, Ward SL. Comparison of nap and overnight polysomnography in children. Pediatr Pulmonol. 1992 May;13(1):16-21. doi: 10.1002/ppul.1950130106.
Background: PubMed 11766164Goodwin JL, Enright PL, Kaemingk KL, Rosen GM, Morgan WJ, Fregosi RF, Quan SF. Feasibility of using unattended polysomnography in children for research--report of the Tucson Children's Assessment of Sleep Apnea study (TuCASA). Sleep. 2001 Dec 15;24(8):937-44. doi: 10.1093/sleep/24.8.937.
Background: PubMed 8606854Jacob SV, Morielli A, Mograss MA, Ducharme FM, Schloss MD, Brouillette RT. Home testing for pediatric obstructive sleep apnea syndrome secondary to adenotonsillar hypertrophy. Pediatr Pulmonol. 1995 Oct;20(4):241-52. doi: 10.1002/ppul.1950200407.
Background: PubMed 16183829Moss D, Urschitz MS, von Bodman A, Eitner S, Noehren A, Urschitz-Duprat PM, Schlaud M, Poets CF. Reference values for nocturnal home polysomnography in primary schoolchildren. Pediatr Res. 2005 Nov;58(5):958-65. doi: 10.1203/01.PDR.0000181372.34213.13. Epub 2005 Sep 23.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Home Respiratory Polygraphy (HRP) and Standard Polysomnography (PSG) in people with Obstructive Sleep Apnea, run by Hospital Universitario Araba at 1 site in Spain.

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 2 inclusion and 7 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: finished, as of the sponsor's last update on 9 Sep 2021. 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 Spain. 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?

Diagnostic validity of a Home Respiratory Polygraphy (HRP) (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03449550, which also lists 19 linked publications.

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 9 Sep 2021.