Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality (SLEEP-ARTerY)
Impact of Sleep on Arterial Function, Psychological and Cognitive Complaints in Hypertensive Patients With Poor Sleep Quality
연구 개요
상태
상세 설명
Background: Poor sleep quality is associated with increased arterial stiffness, depression, and cognitive decline, all of which contribute to cardiovascular risk in hypertensive patients. This trial tests whether improving sleep through CBT-I can attenuate arterial dysfunction and psychological/cognitive burden.
Design: Prospective, single-centre, parallel-group randomised controlled trial with 1:1 allocation, conducted at the Hypertension and Psychiatry Outpatient Clinics of the Unidade Local de Saude Alto Ave (ULSAAVE).
Intervention: CBT-I delivered in four weekly 60-minute sessions (sleep hygiene, stimulus control, relaxation techniques), adapted for participants with mild obstructive sleep apnea or comorbid insomnia and sleep apnea (COMISA).
Comparator: Passive sleep education (informational leaflets plus non-interactive follow-up calls); control participants are offered CBT-I after study completion.
Randomisation and blinding: Computer-generated block randomisation (blocks of 4-6), 1:1 allocation, with allocation concealment via sequentially numbered, opaque, sealed envelopes managed by a third party. Outcome assessors and data analysts are blinded; participants are partially blinded (control presented as an educational intervention).
Sample size: 234 participants (117 per group), accounting for 20% attrition, powered (80%, alpha 0.05) to detect a 0.4 m/s between-group difference in pulse wave velocity at 12 months.
Analysis: Linear mixed-effects models for repeated measures (time as fixed effect, participant as random effect, group as factor), with baseline apnea-hypopnea index included as a covariate.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sofia Gomes, MD
- 전화번호: + 351 253540330
- 이메일: 3603@ulsaave.min-saude.pt
연구 장소
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Braga District
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Guimarães, Braga District, 포르투갈, 4835-044
- 모병
- Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira
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연락하다:
- Sofia Gomes, MD
- 전화번호: +351 253 540 330
- 이메일: 3603@ulsaave.min-saude.pt
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연락하다:
- Pedro Cunha, PhD
- 전화번호: +351 253 540 330
- 이메일: pedrocunha@ulsaave.min-saude.pt
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수석 연구원:
- Sofia Gomes
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부수사관:
- Ana Daniela Ferreira
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18 to 70 years
- Controlled hypertension
- Poor baseline sleep quality (sleep efficiency <=85% assessed via actigraphy or type II polysomnography)
- Capable of providing informed consent
- Participants with mild obstructive sleep apnea (apnea-hypopnea index 5-14.9/h on type II polysomnography) who do not meet criteria for CPAP/PAP therapy are eligible
Exclusion Criteria:
- Severe cardiovascular disease (e.g., acute myocardial infarction or stroke)
- Severe neurological diseases
- Moderate-to-severe obstructive sleep apnea (AHI >=15/h) or any obstructive sleep apnea with an indication for CPAP/PAP therapy
- Central disorders of hypersomnolence
- Intellectual disability
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: CBT-I
Cognitive-behavioural therapy for insomnia: four weekly 60-minute sessions covering sleep hygiene, stimulus control, and relaxation techniques, adapted for participants with mild obstructive sleep apnea or COMISA.
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Cognitive-behavioural therapy for insomnia delivered in four weekly 60-minute sessions, incorporating sleep hygiene, stimulus control, and relaxation techniques.
Based on baseline polysomnography, the protocol is adapted for participants without obstructive sleep apnea, with mild obstructive sleep apnea, or with comorbid insomnia and mild sleep apnea (COMISA).
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활성 비교기: Passive sleep education
Informational leaflets plus non-interactive follow-up calls.
Control participants are offered CBT-I after study completion.
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Passive sleep education consisting of informational leaflets plus non-interactive follow-up calls.
Participants in this control condition are offered access to CBT-I after study completion.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in pulse wave velocity (PWV)
기간: Baseline, 1 month, 6 months, and 12 months
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Change from baseline in carotid-femoral pulse wave velocity (m/s), a marker of arterial stiffness.
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Baseline, 1 month, 6 months, and 12 months
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Change from baseline in central arterial pressure (CAP)
기간: Baseline, 1 month, 6 months, and 12 months
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Change from baseline in central arterial pressure (mmHg).
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Baseline, 1 month, 6 months, and 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in blood pressure
기간: Baseline, 1 month, 6 months, and 12 months
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Change from baseline in systolic and diastolic blood pressure (mmHg)
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Baseline, 1 month, 6 months, and 12 months
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Change from baseline in body weight
기간: Baseline, 1 month, 6 months, and 12 months
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Change from baseline in body weight (kg).
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Baseline, 1 month, 6 months, and 12 months
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Change from baseline in body mass index (BMI)
기간: Baseline, 1 month, 6 months, and 12 months
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Change from baseline in body mass index (kg/m^2).
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Baseline, 1 month, 6 months, and 12 months
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Change from baseline in depressive symptoms (MADRS)
기간: Baseline, 1 month, 6 months, and 12 months
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Change from baseline in depressive symptoms measured by the Montgomery-Asberg Depression Rating Scale (MADRS).
Scores range from 0 to 60, with higher scores indicating more severe depression.
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Baseline, 1 month, 6 months, and 12 months
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Change from baseline in depressive symptoms (PHQ-9)
기간: Baseline, 1 month, 6 months, and 12 months
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Change from baseline in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9).
Scores range from 0 to 27, with higher scores indicating more severe depression.
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Baseline, 1 month, 6 months, and 12 months
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Change from baseline in perceived stress (PSS)
기간: Baseline, 1 month, 6 months, and 12 months
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Change from baseline in perceived stress measured by the Perceived Stress Scale (PSS).
Higher scores indicate greater perceived stress.
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Baseline, 1 month, 6 months, and 12 months
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Change from baseline in cognitive function (MoCA)
기간: Baseline, 1 month, 6 months, and 12 months
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Change from baseline in cognitive function measured by the Montreal Cognitive Assessment (MoCA).
Scores range from 0 to 30, with lower scores indicating greater cognitive impairment.
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Baseline, 1 month, 6 months, and 12 months
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Change from baseline in sleep quality (PSQI)
기간: Baseline, 1 month, 6 months, and 12 months
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Change from baseline in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI).
Scores range from 0 to 21, with higher scores indicating worse sleep quality.
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Baseline, 1 month, 6 months, and 12 months
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Change from baseline in sleep efficiency
기간: Baseline, 1 month, 6 months, and 12 months
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Change from baseline in sleep efficiency (%) assessed via actigraphy or type II polysomnography.
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Baseline, 1 month, 6 months, and 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sofia Gomes, MD, Unidade Local de Saúde do Alto Ave
- 연구 책임자: Pedro Cunha, PhD, Unidade Local de Saúde do Alto Ave
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CIC20260049 - CAIDIS (기타 식별자: ULSAAVE Ethics Committee)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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