Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
31 de agosto de 2026 atualizado por: Silvia Ulrich Somaini
Effect of a One-week Descent From 2850m to Sea Level and Re-ascent in Patients With Pulmonary Arterial Hypertension and Healthy Controls Permanently Living > 2600m on Pulmonary Hemodynamics, Exercise Capacity, Blood Oxygenation, Sleep Disordered Breathing and Further Outcomes
To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level on sleeping parameters by polygraphy in healthy individuals, who live permanently >2600m.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
The aim of this research is to investigate sleeping parameters by polygraphy before and after relocation (high altitude near their living altitude vs. sea level) in healthy individuals, who permanently live at high altitude over 2600m
Tipo de estudo
Intervencional
Inscrição (Estimado)
14
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Silvia Ulrich, Prof. Dr. med.
- Número de telefone: +41442552220
- E-mail: silvia.ulrich@usz.ch
Estude backup de contato
- Nome: Michael Furian, Prof. Dr. sc. ETH
- Número de telefone: +41442552220
Locais de estudo
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Zurich, Suíça, 8091
- University Hospital of Zurich
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Adults aged 18-80 years and of all genders
- Permanent residence > 2600 m
- healthy: no self-perceived cardiopulmonary disease limiting daily activities
- written informed consent to participate in the study
Exclusion Criteria:
- Age <18 years or >80 years
- Participants who cannot follow the study investigations
- Participants permanently living < 2600m.
- Participants who traveled and stayed overnight at altitudes <2000 m in the past 4 weeks.
- any self-perceived cardiopulmonary disease limiting daily activities
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Sleep-parameters at 2850m and at sea level
Assessment of sleep-parameters by polygraphy in healthy individuals at 2850m (pre-descent and after re-ascent) and at sea level in between
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Descent from 2850m to sea level with a stay for 7 days and re-ascent back to 2850m
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean nocturnal SpO2 after 7 days at sea level
Prazo: From high altitude (2850m) to night 7 at sea level
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Difference/change in mean nocturnal SpO2 between 2850m and Night 7 at sea level in healthy individuals
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From high altitude (2850m) to night 7 at sea level
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time spent with low SpO2 after 7 days at sea level
Prazo: From high altitude (2850m) to night 7 at sea level
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Difference/change in time spent with low SpO2 (< 90% and < 80%) between 2850m and night 7 at sea level in healthy individuals
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From high altitude (2850m) to night 7 at sea level
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Apnoea-Hypopnoea-Index AHI after 7 days at sea level
Prazo: From high altitude (2850m) to night 7 at sea level
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Difference/change in nocturnal apnoea-hypopnoea-index between 2850m and night 7 at sea level in healthy individuals
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From high altitude (2850m) to night 7 at sea level
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Oxygen-Desaturation-Index ODI after 7 days at sea level
Prazo: From high altitude (2850m) to night 7 at sea level
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Difference/change in nocturnal Oxygen-Desaturation-Index ODI between 2850m and night 7 at sea level in healthy individuals
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From high altitude (2850m) to night 7 at sea level
|
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Nocturnal cardiovascular autonomic control after 7 days at sea level
Prazo: From high altitude (2850m) to night 7 at sea level
|
Difference/change in nocturnal cardiovascular autonomic control by heart rate (variability) between 2850m and night 7 at sea level in healthy individuals
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From high altitude (2850m) to night 7 at sea level
|
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Acclimatization-Effect of mean nocturnal SpO2 at sea level
Prazo: From Night 1 to Night 7 at sea level
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Difference/change in mean nocturnal SpO2 at night 1 and night 7 within a stay at sea level of 7 days (after relocation from high altitude) in healthy individuals
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From Night 1 to Night 7 at sea level
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Acclimatization-Effect of time spent with low SpO2 at sea level
Prazo: From Night 1 to Night 7 at sea level
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Difference/change in time spent with low SpO2 (< 90% and < 80%) at night 1 and night 7 within a stay at sea level of 7 days (after relocation from high altitude) in healthy individuals
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From Night 1 to Night 7 at sea level
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Acclimatization-Effect of Apnoea-Hypopnoea-Index AHI at sea level
Prazo: From Night 1 to Night 7 at sea level
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Difference/change in nocturnal apnoea-hypopnoea-index at night 1 and night 7 within a stay at sea level of 7 days (after relocation from high altitude) in healthy individuals
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From Night 1 to Night 7 at sea level
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Acclimatization-Effect of Oxygen-Desaturation-Index ODI at sea level
Prazo: From Night 1 to Night 7 at sea level
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Difference/change in nocturnal oxygen-desaturation-index at night 1 and night 7 within a stay at sea level of 7 days (after relocation from high altitude) in healthy individuals
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From Night 1 to Night 7 at sea level
|
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Acclimatization-Effect of nocturnal cardiovascular autonomic control at sea level
Prazo: From Night 1 to Night 7 at sea level
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Difference/change in nocturnal cardiovascular autonomic control by heart rate (variability) at night 1 and night 7 within a stay at sea level of 7 days (after relocation from high altitude) in healthy individuals
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From Night 1 to Night 7 at sea level
|
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Mean nocturnal SpO2 after re-ascent to 2850m
Prazo: From Night 7 at sea level to night after reascent (time frame of 3 days)
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Difference/change in mean nocturnal SpO2 between sea level (after one-week stay) and night after re-ascent to 2850m in healthy individuals
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From Night 7 at sea level to night after reascent (time frame of 3 days)
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Time spent with low SpO2 after re-ascent to 2850m
Prazo: From Night 7 at sea level to night after re-ascent (time frame of 3 days)
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Difference/change in time spent with low SpO2 (< 90% and < 80%) between sea level (after one-week stay) and night after re-ascent to 2850m in healthy individuals
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From Night 7 at sea level to night after re-ascent (time frame of 3 days)
|
|
Apnoea-Hypopnoea-Index AHI after re-ascent to 2850m
Prazo: From Night 7 at sea level to night after re-ascent (time frame of 3 days)
|
Difference/change in nocturnal apnoea-hypopnoea-index between sea level (after one-week stay) and night after re-ascent to 2850m in healthy individuals
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From Night 7 at sea level to night after re-ascent (time frame of 3 days)
|
|
Oxygen-Desaturation-Index ODI after re-ascent to 2850m
Prazo: From Night 7 at sea level to night after re-ascent (time frame of 3 days)
|
Difference/change in nocturnal oxygen-desaturation-index between sea level (after one-week stay) and night after re-ascent to 2850m in healthy individuals
|
From Night 7 at sea level to night after re-ascent (time frame of 3 days)
|
|
Nocturnal cardiovascular autonomic control after re-ascent to 2850m
Prazo: From Night 7 at sea level to night after re-ascent (time frame of 3 days)
|
Difference/change in nocturnal cardiovascular autonomic control by heart rate (variability) between sea level (after one-week stay) and night after re-ascent to 2850m in healthy individuals
|
From Night 7 at sea level to night after re-ascent (time frame of 3 days)
|
|
Mean nocturnal SpO2 pre-descent and after re-ascent (2850m)
Prazo: From the night at 2850m prior to the descent, stay at sea level of one week in between, to the night after re-ascent to 2850m (time frame approximately 11 days)
|
Difference/change in mean nocturnal SpO2 between the night at 2850m prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in healthy individuals
|
From the night at 2850m prior to the descent, stay at sea level of one week in between, to the night after re-ascent to 2850m (time frame approximately 11 days)
|
|
Time spent with low SpO2 pre-descent and after re-ascent (2850m)
Prazo: From the night at 2850m prior to the descent, stay at sea level of one week in between, to the night after re-ascent to 2850m (time frame approximately 11 days)
|
Difference/change in time spent with low SpO2 (< 90% and < 80%) between the night at 2850m prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in healthy individuals
|
From the night at 2850m prior to the descent, stay at sea level of one week in between, to the night after re-ascent to 2850m (time frame approximately 11 days)
|
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Apnoea-Hypopnoea-Index AHI pre-descent and after re-ascent (2850m)
Prazo: From the night at 2850m prior to the descent, stay at sea level of one week in between, to the night after re-ascent to 2850m (time frame approximately 11 days)
|
Difference/change in nocturnal apnoea-hypopnoea-index between the night at 2850m prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in healthy individuals
|
From the night at 2850m prior to the descent, stay at sea level of one week in between, to the night after re-ascent to 2850m (time frame approximately 11 days)
|
|
Oxygen-Desaturation-Index ODI pre-descent and after re-ascent (2850m)
Prazo: From the night at 2850m prior to the descent, stay at sea level of one week in between, to the night after re-ascent to 2850m (time frame approximately 11 days)
|
Difference/change in nocturnal oxygen-desaturation-index between the night at 2850m prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in healthy individuals
|
From the night at 2850m prior to the descent, stay at sea level of one week in between, to the night after re-ascent to 2850m (time frame approximately 11 days)
|
|
Nocturnal cardiovascular autonomic control pre-descent and after re-ascent (2850m)
Prazo: From the night at 2850m prior to the descent, stay at sea level of one week in between to the night after re-ascent to 2850m (time frame approximately 11 days)
|
Difference/change in nocturnal cardiovascular autonomic control by heart rate (variability) between the night at 2850 prior to the descent to sea level (stay of 7 days at sea level in between) and the night at 2850m after re-ascent in healthy individuals
|
From the night at 2850m prior to the descent, stay at sea level of one week in between to the night after re-ascent to 2850m (time frame approximately 11 days)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Silvia Ulrich, University Hospital Zurich, Departement of Pulmonology
- Investigador principal: Rodrigo Hoyos, Hospital Carlos Andrade Marin of Quito, Ecuador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
25 de setembro de 2026
Conclusão Primária (Estimado)
4 de outubro de 2026
Conclusão do estudo (Estimado)
31 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
17 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de agosto de 2026
Primeira postagem (Real)
3 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Ec_HAvsLA_sleep_H
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Data will be provided upon request and based on a clear intention reviewed by an ethical review board.
Informações sobre medicamentos e dispositivos, documentos de estudo
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Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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