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Obstructive Sleep ApneaNCT04252482

Validation of Sleep Healthcare System

A study testing CPAP in people with Obstructive Sleep Apnea, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

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

Official record
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Trial summary

The present project aims to that examine the interplay between sleep duration circadian phase, and metabolic regulation. The impact of CPAP therapy on metabolic regulation is assessed with a RCT. Patients were enrolled form referral to sleep clinic for suspect obstructive sleep apnea (OSA). Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
CPAP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteTaiwan
Study dates
7 Feb 2020to 27 Apr 2023
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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • >=20 year-old
  • patients with moderate-severe OSA (AHI≥15/hr)

Who cannot join

  • skin allergy
  • wrist tattoos
  • BMI≧40 kg/m2
  • Neurological Disorders(Infection, Stroke, ALS, Myopathy, Brain tumor and Encephalitis)
  • Internal Diseases(cardiovascular disease or coronary artery disease was poorly controlled
  • chronic heart failure(including NYHA class 3 or more than NYHA class 3)
Show all 21Show fewer
  • COPD(FEV1/FVC<70)
  • Hyperthyroidism or Hypothyroidism
  • Primary Aldosteronism
  • Chronic Kidney Disease(eGFR<30)
  • Acromegaly and Parkinson's disease)
  • Psychosis(Schizophrenia, bipolar disorder and depression)
  • Autoimmune disease(System Lupus Erythematosus, Rheumatoid arthritis, Sarcoidosis, Crohn's disease and Ulcerative Colitis)
  • Cancer(in last 5 years)
  • Have been diagnosed with obstructive sleep apnea
  • other sleep disorder(Narcolepsy, insomnia and RBD)
  • Use anti-inflammatory drugs(in last 2 weeks)
  • Illiterate
  • shift worker
  • has been Spinal Surgery and move difficult
  • professional driver has severe drowsiness

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Center of sleep disorders, National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

The present project aims to that examine the interplay between sleep duration circadian phase, and metabolic regulation. The impact of CPAP therapy on metabolic regulation is assessed with a RCT. Patients were enrolled form referral to sleep clinic for suspect obstructive sleep apnea (OSA). Subjects with hypopnea index (AHI) >=15/h are randomly allocated to the usual care or Auto-PAP (APAP) therapy then reevaluated after 12th week. The CPAP effect are measured with the comparison of changes in outcomes between usual care and APAP therapy.

Read the detailed description

Enrolled participants undertake pre-randomization evaluations. That included standard questionnaire, eating behavior, International Physical Activity Questionnaire (IPAQ)-short form, 3-day dietary intake, and 7-day sleep log, 24-hr ambulatory blood pressure, and 7-day Actiwatch. Within one week after completion, participants underwent repeated polysomnography (PSG) to confirm the diagnosis of OSA. The basal metabolic rate (BMR) and body composition (BC), and blood sampling are conducted in the morning next to overnight PSG and BMR.

Once the pre-randomization evaluation was completed and the AHI >=15/h was confirmed, participants are randomly allocated to the usual care or auto-CPAP treatment (AirSense™ 10 Autoset™, ResMed Inc., Australia) for 12 weeks. Participants had two follow-up visits at 4th and 12th week and were reevaluated with the same measurements as pre-randomization Enrolled participants are randomized into CPAP or usual care. The randomization is generated by the staff of the Department of Biostatistics independent of subject enrolment. A block-randomized assignment with a block size of four is used. Consecutive patients are assigned to the allocation according to the randomization schedule by the study nurse. Investigators who assess outcome are blinded to the allocation assignment. Preset-dropout criteria: Defaulting clinic visits at 4th and 12-week, re-assessment, and clinical exacerbations requiring medical attention.

Participants starting CPAP are instructed to use the device for >=6hr/night. PAP compliance is assessed as the average usage hours per night which is objectively recorded on the devices with a built-in compliance meter. Compliance data are downloaded by medical staff at every clinic visit. The good compliance is defined as usage>= 4hr/night in 70% days of total period.

Being tested
CPAP
Keywords
basal metabolism, body weight, energy intake, energy metabolism, insulin resistance
Medical subject headings
Sleep Apnea, Obstructive, Body Weight, Insulin Resistance

What participants receive

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

  • CPAPDevice

    Auto-CPAP treatment (AirSense™ 10 Autoset™, ResMed Inc., Australia) for 12 weeks

Study groups in NCT04252482
Study groupRoleWhat they receive
Use of CPAP deviceExperimentalCPAP 12 weeks
Receives: Device: CPAP
Usual careNo interventionUsual care 12 weeks

What is being measured

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

  1. The difference before and after the treatment of BMR (REE)

    The difference in BMR(Basal metabolic rate) between the CPAP group and the usual care group. The comparison item is REE(Resting Energy Expenditure) (kcal/day)

    Measured: 12 weeks

Secondary outcomes (6)

  1. The difference before and after the treatment of BC(total fat mass and fat free mass)

    Compare the total fat mass and fat free mass between the usual care group and the CPAP group to demonstrate the effectiveness before and after treatment. The units for total fat mass and fat free mass are both in kg.

    Measured: 12 weeks

  2. The difference before and after the treatment of energy intake and percentage of nutrients

    The difference before and after treatment is represented by comparing the calorie intake from the three-day food diaries between the usual care group and the CPAP group. The evaluation unit is total calories (% nutrition).

    Measured: 12 weeks

  3. The difference before and after the treatment of eating behavior

    Compare the eating behavior between the usual care group and the CPAP group to demonstrate the differences before and after treatment. Eating behavior includes cognitive restraint, uncontrolled eating, and emotional eating, which are assessed using the 18 items of the Three-Factor Eating Questionnaire(TFEQ).

    Measured: 12 weeks

  4. The difference before and after the treatment of 24h blood pressure

    The difference in 24-h systolic, diastolic(mmHg), and mean BP(mmHg) between the CPAP group and the usual care group.

    Measured: 12 weeks

  5. The difference before and after the treatment of sleep parameters

    The difference before and after treatment is represented by comparing sleep parameters (hours of sleep, TIB, sleep efficiency) between the usual care group and the CPAP group. The activity levels are measured using an Actiwatch (Spectrum Plus, Philips Respironics, USA).

    Measured: 12 weeks

  6. The difference before and after the treatment of Physical Activity(PA)

    Compare the difference between participants' self-reported International Physical Activity Questionnaire-Short Form(IPAQ-SF) questionnaire and the objectively measured physical activity from the Actiwatch to demonstrate the effectiveness of CPAP treatment. The IPAQ-SF primarily analyzes total physical activity (MET time/week) and the percentage of vigorous-intensity activity, while the Actiwatch analyzes the average activity count per minute measured by the device.

    Measured: 12 weeks

Timeline

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

  1. First posted5 Feb 2020
  2. Study start7 Feb 2020
  3. Primary completion8 Dec 2022
  4. Study completion27 Apr 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04252482
Sponsor's protocol ID
201802034RIPD
Status last verified
Apr 2024
First submitted
30 Jan 2020
Last updated
15 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee PL, Chien MY, Lai SR, Gooley JJ, Feng HC, Chen SK, Lin MT, Chen YH, Chiu HC, Liu PK, Ku BW, Wang SM, Chang CH, Yang WS, Yu CJ. Continuous positive airway pressure effects on energy expenditure, intake, hormonal regulation, and body composition: a randomized trial. Sleep. 2026 Jan 13;49(1):zsaf259. doi: 10.1093/sleep/zsaf259.

    PubMed 40874641

  • Liu PK, Ting N, Chiu HC, Lin YC, Liu YT, Ku BW, Lee PL. Validation of photoplethysmography- and acceleration-based sleep staging in a community sample: comparison with polysomnography and Actiwatch. J Clin Sleep Med. 2023 Oct 1;19(10):1797-1810. doi: 10.5664/jcsm.10690.

    PubMed 37338335

Questions about this trial

What is this clinical trial studying?

A study testing CPAP in people with Obstructive Sleep Apnea, run by National Taiwan University Hospital at 1 site in Taiwan.

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 21 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 15 Jan 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 Taiwan. 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?

The difference before and after the treatment of BMR (REE) (time frame: 12 weeks). 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 NCT04252482, which also lists 2 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 15 Jan 2025.

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