<?xml version="1.0" encoding="utf-8"?>
<trials>
  <trial>
    <main>
      <trial_id>TCTR20210331002</trial_id>
      <utrn/>
      <reg_name>TCTR</reg_name>
      <date_registration>31/03/2021</date_registration>
      <primary_sponsor>Thammasat University Hospital</primary_sponsor>
      <public_title>Comparison in Therapeutic Pressure between Home Automatic Positive Airway Pressure and Laboratory Polysomnography Manual Titration in Thai Patient with Obstructive Sleep Apnea</public_title>
      <acronym/>
      <scientific_title>Comparison in Therapeutic Pressure between Home Automatic Positive Airway Pressure and Laboratory Polysomnography Manual Titration in Thai Patient with Obstructive Sleep Apnea</scientific_title>
      <scientific_acronym/>
      <date_enrolment>02/04/2021</date_enrolment>
      <type_enrolment>Anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Pending (Not yet recruiting)</recruitment_status>
      <url>www.thaiclinicaltrials.org/show/TCTR20210331002</url>
      <study_type>Observational</study_type>
      <study_design/>
      <phase/>
      <hc_freetext>Obstructive sleep apnea (OSA)</hc_freetext>
      <i_freetext>OSA patients aged 18 years or older with AHI 5 events/h or more</i_freetext>
      <results_actual_enrolment/>
      <results_date_completed>31/08/2021</results_date_completed>
      <results_url_link/>
      <results_summary/>
      <results_date_posted/>
      <results_date_first_publication/>
      <results_baseline_char/>
      <results_participant_flow/>
      <results_adverse_events/>
      <results_outcome_measures/>
      <results_url_protocol/>
      <results_IPD_plan>No</results_IPD_plan>
      <results_IPD_description>No source of data sharing</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narongkorn</firstname>
        <middlename/>
        <lastname>Saiphoklang</lastname>
        <address>99/209 Paholyotin Road</address>
        <city>Pathum Thani</city>
        <country1>Thailand</country1>
        <zip>12120</zip>
        <telephone>029269794</telephone>
        <email>M_narongkorn@hotmail.com</email>
        <affiliation>Thammasat university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narongkorn</firstname>
        <middlename/>
        <lastname>Saiphoklang</lastname>
        <address>99/209 Paholyotin Road</address>
        <city>Pathum Thani</city>
        <country1>Thailand</country1>
        <zip>12120</zip>
        <telephone>6629269794</telephone>
        <email>M_narongkorn@hotmail.com</email>
        <affiliation>Thammasat University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Thailand</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. OSA patients aged 18 years or older, 2. Undergoing polysomnography in laboratory, 3. apnea-hypopnea index (AHI) 5 events/h or more</inclusion_criteria>
      <agemin>18 Years</agemin>
      <agemax> N/A (No limit)</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Intolerance to CPAP treatment, 2. Need BiPAP treatment, 3. Contraindications for CPAP; central sleep apnea, congestive heart failure, myocardial infarction, obesity hypoventilation syndrome, chronic obstructive lung disease, 4. Comorbidities; acute stroke, allergic rhinitis, uncontrolled epilepsy, acute neurological or psychiatric disorders, 5. Medications; sedative or antiepileptic drugs, 6. Claustrophobia, 7. Tracheostomy, 8. Pregnancy or lactation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code/>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obstructive sleep apnea &#13;
Continuous positive airway pressure&#13;
Polysomnography</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>OSA patients</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pressure of CPAP manual titration in laboratory At the beginning of study cmH2O,Pressure of home automatic CPAP At 1 week cmH2O</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>AHI of OSA At the beginning of study events/h</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name/>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>Nil Known</sec_id>
        <issuing_authority/>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Thammasat University Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Submitted, approved</status>
        <approval_date>02/07/2020</approval_date>
        <contact_name>Human Research Ethics Committee of Thammasat University No.1 (Faculty of Medicine)</contact_name>
        <contact_address>99/209 Paholyotin Road, Klong Luang, Pathum Thani, Thailand 12120</contact_address>
        <contact_phone>6629269704 Ext. 7535</contact_phone>
        <contact_email>ec.medtu@gmail.com</contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
