NCT04252482

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

February 7, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2023

Completed
Last Updated

January 15, 2025

Status Verified

April 1, 2024

Enrollment Period

2.8 years

First QC Date

January 30, 2020

Last Update Submit

January 13, 2025

Conditions

Obstructive Sleep Apnea

Keywords

basal metabolismbody weightenergy intakeenergy metabolisminsulin resistance

Outcome Measures

Primary Outcomes (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)

    12 weeks

Secondary Outcomes (6)

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

    12 weeks

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

    12 weeks

  • The difference before and after the treatment of eating behavior

    12 weeks

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

    12 weeks

  • The difference before and after the treatment of sleep parameters

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Use of CPAP device

EXPERIMENTAL

CPAP 12 weeks

Device: CPAP

Usual care

NO INTERVENTION

Usual care 12 weeks

Interventions

CPAPDEVICE

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

Use of CPAP device

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of sleep disorders, National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (2)

  • 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.

    PMID: 40874641DERIVED

  • 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.

    PMID: 37338335DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveBody WeightInsulin Resistance

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Pei-Lin Lee, M.D., PhD

    Department of Internal Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

February 7, 2020

Primary Completion

December 8, 2022

Study Completion

April 27, 2023

Last Updated

January 15, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)