NCT02329470

Brief Summary

Background: Patients with obstructive sleep apnea run an increased risk of cardiovascular disease including hypertension. Continuous positive airway pressure (CPAP) is the first line of treatment. However, many patients skip CPAP for some nights. Aims: The primary aim was to investigate the cardiovascular effects of short-term CPAP withdrawal for five nights because of obstructive sleep apnea. Design: Randomized, parallel controlled trial Inclusion criteria: 100 patients with successful CPAP treatment for moderate to severe obstructive sleep apnea. Exclusion criteria: Dementia, heart infarction within 3 months, apnea hypopnea index \> 10 with CPAP treatment. Randomization: 50 patients are randomized to sleep 5 days without CPAP and 50 patients to continue with CPAP treatment during the trial. Primary outcomes: Arterial stiffness, 24-hour blood pressure. Secondary outcomes: Effects of gender on outcome. Effects on brain natriuretic peptide, apnea-hypopnea index, oxygen desaturation-index, urine-catecholamines, blood lipids, C-reactive protein, glucose metabolism (S-glc, HBA1c), insulin resistance, serum creatinine, hemoglobin, daytime sleepiness (ESS, KSS), lung function (FVC, FEV1), airway inflammation (exhaled NO) Procedures: Sleep apnea investigation while patients are treated with CPAP for one night. Urinary samplings during the same night. They are also investigated with 24 h blood pressure measurements. Blood samples are taking fasting in the morning followed by measuring the arterial stiffness (Vicorder, Skidmore Medical UK) including pulse wave analysis using sphygmomanometer (Omron Japan). The same investigations are done at follow-up 5 days later where half of the patients have continued using CPAP treatment and half of them has slept without CPAP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

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

December 12, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

December 18, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
Last Updated

March 3, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

December 12, 2014

Last Update Submit

February 28, 2023

Conditions

Obstructive Sleep ApneaCardiovascular Disease

Outcome Measures

Primary Outcomes (2)

  • Arterial stiffness.

    Arterial stiffness measured with Vicorder and pulse wave analysis

    5 days

  • Systolic and diastolic blood pressure

    24 hour blood pressure measurements

    5 days

Secondary Outcomes (18)

  • Gender differences

    5 days

  • Effect on myocardial function

    5 days

  • Impact on apnea hypopnea index

    5 days

  • Effect on oxygen saturation

    5 days

  • Effect on catecholamines

    5 days

  • +13 more secondary outcomes

Study Arms (2)

No device, n=50

EXPERIMENTAL

Withdrawal of device, continuous positive airway pressure treatment during 5 nights

Procedure: Withdrawal of continuous positive airway pressure treatment

Continue using device, continuous positive airway pressure treatment n=50

NO INTERVENTION

Control group, Continue with device, continuous positive airway pressure treatment

Interventions

Withdrawal of continuous positive airway pressure treatmentPROCEDURE

Withdrawal of continuous positive airway pressure treatment

No device, n=50

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older,
  • given the written consent to participate in the study,
  • moderate sleep apnea with Apnea Hypopnea Index \>15 before treatment

You may not qualify if:

  • Apnea hypopnea index \> 10 with CPAP treatment,
  • heart infarction within 3 months prior to study participation,
  • severe dementia,
  • determined by study personal having psychological or physical hinder to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Respiratory Medicine

Umeå, 901 85, Sweden

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveCardiovascular Diseases

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Karl A Franklin, Prof, MD

    umea University

    PRINCIPAL INVESTIGATOR

  • Carin Sahlin, PhD

    Umea University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass Prof

Study Record Dates

First Submitted

December 12, 2014

First Posted

December 31, 2014

Study Start

December 18, 2014

Primary Completion

August 31, 2016

Study Completion

August 31, 2016

Last Updated

March 3, 2023

Record last verified: 2023-02

Locations

SE(1)